Anxiety, Critical Illness, Respiratory Failure
Conditions
Brief summary
The purpose of this randomized clinical trial is to test the efficacy of dexmedetomidine for the self-management of sedative therapy (SMST) in a sample of critically ill patients receiving mechanical ventilator support. The investigators hypothesis is that self-management of sedative therapy by mechanically ventilated patients in the intensive care unit (ICU), tailored to their individual needs will be more efficacious than nurse-administered sedative therapy in reducing anxiety, which may reduce duration of mechanical ventilator support and occurrence of delirium.
Detailed description
The overall objective of this study is to demonstrate efficacy for conducting a future, pragmatic effectiveness trial to test whether self-management of sedative therapy (SMST) is superior to nurse-administered sedative therapy in day-to-day intensive care unit (ICU) practice. This efficacy trial is powered for the investigators primary, clinically relevant endpoints (anxiety, duration of mechanical ventilation, and delirium presence), and examines patient outcomes adversely affected by sedative administration practices, such as prolonged ICU stays, altered mental status, and diminished post-ICU quality of life. This randomized clinical trial with a total of 190 mechanically ventilated patients enrolled and maintained on protocol will address the following Specific Aims. The primary aim is to determine the efficacy of SMST compared to nurse-administered sedative therapy on anxiety, duration of mechanical ventilation, and presence of delirium in mechanically ventilated patients (MVPs). The secondary aim is to compare level of arousal and sedative exposure in mechanically ventilated patients (MVPs) randomized to SMST to those MVPs receiving nurse-administered sedative therapy. The investigators hypothesize that SMST patients will be easily arousable, more alert, and exposed to less sedation than those who receive nurse-administered sedative therapy. Exploratory aims are to compare post-ICU outcomes (physical/functional status, psychological well-being, and health-related quality of life) and recall of ICU experiences between MVPs randomized to SMST and those receiving nurse-administered sedative therapy.
Interventions
DRUGDexmedetomidine
Patient will receive a maintenance intravenous infusion of medication (Dexmedetomidine) and have access to self-controlled sedation medication (Dexmedetomidine) for anxiety.
Sponsors
University of Minnesota
National Heart, Lung, and Blood Institute (NHLBI)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is acutely mechanically ventilated during the current hospitalization. 2. Subject is currently receiving a continuous intravenous infusion of a sedative/opioid medication(s) or has received at least one intravenous bolus dose of a sedative/opioid medication in the previous 24 hours (fentanyl, hydromorphone, ketamine, morphine, midazolam, diazepam, lorazepam, propofol, haloperidol, dexmedetomidine). 3. Subject must pass pre-Patient-Controlled Sedation (PCS) screening test and be assessed Richmond Agitation-Sedation Scale (RASS) -2 to +1 4. Subject Age ≥ 18 years 5. Subject or their proxy is capable of providing informed consent
Exclusion criteria
1. Aggressive ventilatory support or prone ventilation. 2. Hypotension (systolic blood pressure \< 85 mmHg) requiring a vasopressor at a dose greater than norepinephrine or epinephrine 0.15 mcg/kg/min or vasopressin \> 2.4 units per hour. Subjects will be excluded if they require more than one continuous infusion of a catecholamine vasopressor medication simultaneously. Subjects will be excluded if the vasopressor dose was higher than norepinephrine or epinephrine 0.15 mcg/kg/min, vasopressin \> 2.4 units per hour, phenylephrine \>3 mcg/kg/min, dopamine \>10 mcg/kg/min or dobutamine at any dose in the prior 6 hours. If dopamine is being used to increase heart rate, rather than as a vasopressor for hypotension, subject will be excluded. 3. Second or third degree heart block or bradycardia (heart rate \< 50 beats/min). 4. Paralysis or other condition preventing the use of push button device 5. Positive pregnancy test or lactation 6. Acute hepatitis or liver failure (direct bilirubin \>5 mg/dL) 7. Acute stroke or uncontrolled seizures. 8. Acute myocardial infarction within 48 hours prior to enrollment. 9. Severe cognition or communication problems (such as coma, deafness without signing literacy, physician-documented dementia) 10. Assessed RASS -3, -4, -5 or RASS +2,+3, +4 11. Chronic ventilator support in place of residence prior to current hospitalization. 12. Imminent extubation from mechanical ventilator support.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Rating Using the 100mm Vertical Visual Analog Scale | 7 days | Vertical visual analog scale will be used to measure level of state anxiety from 0/zero (no anxiety) to 100 (most anxiety ever). Higher scores mean more anxiety. |
| Duration of Mechanical Ventilatory Support After Study Enrollment | 7 days | Duration of time (hours) patients received mechanical ventilatory support after randomization to either Control or dexmedetomidine self-management of sedative therapy to extubation. |
| Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) | 7 days | Confusion Assessment Method-ICU (CAM-ICU) used to assess for the presence (CAM-ICU+) or absence (CAM-ICU-) of delirium at each assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | 7 days | The Richmond Agitation-Sedation Scale (RASS) was used to assess the level of alertness and agitation in enrolled patients. Scores range from -5 to +4. RASS 0/zero indicates alert and calm patient. Negative scores (-1 to -5) indicate increasing level of sedation with -5 indicating unarousable. Positive scores indicate increasing agitation (+1 to +4) with +4 indicating a combative patient. For enrolled study patients, RASS score -2 (light sedation) to +1 (restless) was considered in range. We report here the total number of patients assessed as outside the desirable range of RASS score -5 to -3 and +2 to +4 by each ICU study day. |
| Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Daily Sedation intensity over a 7-day ICU study protocol period | Sedation intensity combines the number of sedative doses and the dose amount of any of 9 intravenous (IV) sedative medications (lorazepam, midazolam, propofol, morphine, hydromorphone, dexmedetomidine, fentanyl, haloperidol, ketamine) recorded in the electronic health record, summarized over all patients and time periods each day to obtain medians and quartiles. Each of the 9 sedative drugs administered during each 4-hr period is then assigned a ranking: 0 for drug not used, 1 for the bottom quartile, 2 for the second quartile, 3 for the third, and 4 for the fourth. A score is determined by summing for the 24-hr day over the 6, 4-hour blocks to produce a daily Sedation Intensity Score from 0-36, higher score more intense dosing received of sedative medications. |
| Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Daily Sedation Frequency over a 7-day ICU study protocol period | Sedation Frequency is the number of individual intravenous (IV) sedative medication(s) doses administered to patients over each 24-hour day of lorazepam, midazolam, propofol, morphine, hydromorphone, dexmedetomidine, fentanyl, haloperidol, ketamine. Sedation frequency ranges from 0-216 with a higher number indicating more frequent receipt of a sedative medication(s). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Using Personal or Emotional Health Domain | 6 months after ICU discharge over the telephone Role Limitations due to Personal or Emotional Health | Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales. |
| Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Using the Energy/Fatigue Domain | 3 months after ICU discharge over the telephone Energy/Fatigue Domain | Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales. |
| Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Emotional Well-being Domain | 3 months after ICU discharge over the telephone Emotional Well-being | Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales. |
| Comparison of Post-ICU Physical Status Using the Katz Activities of Daily Living Scale | Independence in activities of daily living at 3 months and 6 months after hospital discharge over the telephone | Physical status will be assessed by the Katz Activities of Daily Living scale to assess basic physical abilities like bathing, feeding with 6 questions. Higher scores of 6 indicates the individual is independent, whereas a score of 0 indicates the individual is very dependent. |
| Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Socia Functioning Domain | 6 months after ICU discharge over the telephone social functioning | Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales. |
| Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Bodily Pain Domain | 3 months after ICU discharge over the telephone bodily pain | Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales. |
| Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 General Health Domain | 3 months after ICU discharge over the telephone general health perceptions | Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales. |
| Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Social Functioning Domain | 3 months after ICU discharge over the telephone social functioning | Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales. |
| Comparison of Post-ICU Psychological Well-being Status Using the Patient Health Questionnaire-9 | 3 and 6 months after ICU discharge over the telephone | Psychological well-being will be assessed by the Patient Health Questionnaire (PHQ-9) is a 9-item tool that tracks symptoms of major depression. Scores range from 9-36, with higher scores indicating altered psychological well-being. |
| Comparison of Post-ICU Psychological Well-being Status Using the Posttraumatic Stress Disorder Checklist Event Specific (PCL) Scale | 3 months and 6 months after ICU discharge over the telephone | Psychological well-being will be assessed with the Posttraumatic Stress Disorder Checklist Event Specific (PCL) to measure symptoms of posttraumatic stress disorder after a stressful life experience of ICU admission. Scores range from 17-85 with higher scores indicating being symptomatic for posttraumatic stress. |
| Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Physical Function Domain | 3 months after ICU discharge over the telephone Physical Function Domain | Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 (SF-36) at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales. |
| Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Role Limitations Domain | 3 months after ICU discharge over the telephone Role Limitations Domain due to Physical Health | Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales. |
| Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Personal or Emotional Health Domain | 3 months after ICU discharge over the telephone Role Limitations due to Personal or Emotional Health | Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team | 81 |
| Dexmedetomidine These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety.
Dexmedetomidine: Patient will receive a maintenance intravenous infusion of medication (Dexmedetomidine) and have access to self-controlled sedation medication (Dexmedetomidine) for anxiety. | 80 |
| Total | 161 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Extubated or discontinued prior to day 7 | 6 | 20 |
Baseline characteristics
| Characteristic | Total | Dexmedetomidine | Control |
|---|---|---|---|
| Acute Physiology and Chronic Health Evaluation (APACHE) III score | 82 units on a scale | 85.5 units on a scale | 80.0 units on a scale |
| Age, Continuous | 58.9 years STANDARD_DEVIATION 15.1 | 56.2 years STANDARD_DEVIATION 16 | 61.5 years STANDARD_DEVIATION 13.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 160 Participants | 79 Participants | 81 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 149 Participants | 74 Participants | 75 Participants |
| Region of Enrollment United States | 161 Participants | 80 Participants | 81 Participants |
| Sex: Female, Male Female | 73 Participants | 35 Participants | 38 Participants |
| Sex: Female, Male Male | 88 Participants | 45 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 81 | 0 / 80 |
| other Total, other adverse events | 29 / 81 | 24 / 80 |
| serious Total, serious adverse events | 5 / 81 | 12 / 80 |
Outcome results
Primary
Anxiety Rating Using the 100mm Vertical Visual Analog Scale
Vertical visual analog scale will be used to measure level of state anxiety from 0/zero (no anxiety) to 100 (most anxiety ever). Higher scores mean more anxiety.
Time frame: 7 days
Population: Not all enrolled patients able to respond to each assessment time point for anxiety ratings. They may have been extubated and completed the ICU study phase, withdrew from the study, or died.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 1 evening | 45.1 score on a scale | Standard Deviation 32.4 |
| Control | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 2 morning | 49.8 score on a scale | Standard Deviation 30.9 |
| Control | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 2 afternoon | 41.9 score on a scale | Standard Deviation 33.4 |
| Control | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 2 evening | 50.9 score on a scale | Standard Deviation 32.7 |
| Control | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 6 morning | 39.5 score on a scale | Standard Deviation 31.1 |
| Control | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 6 afternoon | 33.1 score on a scale | Standard Deviation 28 |
| Control | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 1 morning | 44.4 score on a scale | Standard Deviation 33.2 |
| Control | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 1 afternoon | 40.5 score on a scale | Standard Deviation 31.8 |
| Control | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 3 morning | 48 score on a scale | Standard Deviation 35 |
| Control | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 3 afternoon | 43.3 score on a scale | Standard Deviation 33.9 |
| Control | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 3 evening | 47.3 score on a scale | Standard Deviation 39.2 |
| Control | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 4 morning | 43.4 score on a scale | Standard Deviation 35 |
| Control | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 4 afternoon | 43.3 score on a scale | Standard Deviation 35.5 |
| Control | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 4 evening | 48.2 score on a scale | Standard Deviation 34.7 |
| Control | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 5 morning | 49.1 score on a scale | Standard Deviation 31.6 |
| Control | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 5 afternoon | 39.6 score on a scale | Standard Deviation 27.4 |
| Control | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 5 evening | 50.7 score on a scale | Standard Deviation 37.6 |
| Control | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 6 evening | 55.7 score on a scale | Standard Deviation 33.1 |
| Control | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 7 morning | 47.0 score on a scale | Standard Deviation 29.3 |
| Control | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 7 afternoon | 34.4 score on a scale | Standard Deviation 35.8 |
| Dexmedetomidine | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 3 afternoon | 58.6 score on a scale | Standard Deviation 40.1 |
| Dexmedetomidine | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 1 evening | 40.9 score on a scale | Standard Deviation 35.7 |
| Dexmedetomidine | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 5 morning | 36.1 score on a scale | Standard Deviation 32.3 |
| Dexmedetomidine | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 2 morning | 44.6 score on a scale | Standard Deviation 34.4 |
| Dexmedetomidine | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 3 evening | 48.1 score on a scale | Standard Deviation 33.1 |
| Dexmedetomidine | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 2 afternoon | 41.4 score on a scale | Standard Deviation 38.5 |
| Dexmedetomidine | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 7 morning | 74.4 score on a scale | Standard Deviation 14.9 |
| Dexmedetomidine | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 4 morning | 52.4 score on a scale | Standard Deviation 30.8 |
| Dexmedetomidine | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 6 morning | 46.1 score on a scale | Standard Deviation 31.4 |
| Dexmedetomidine | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 5 afternoon | 32.0 score on a scale | Standard Deviation 28.7 |
| Dexmedetomidine | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 6 afternoon | 53.3 score on a scale | Standard Deviation 26.9 |
| Dexmedetomidine | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 7 afternoon | 30.8 score on a scale | Standard Deviation 14.8 |
| Dexmedetomidine | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 4 afternoon | 51.4 score on a scale | Standard Deviation 36.9 |
| Dexmedetomidine | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 1 morning | 43.4 score on a scale | Standard Deviation 33.4 |
| Dexmedetomidine | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 6 evening | 38.0 score on a scale | Standard Deviation 34.4 |
| Dexmedetomidine | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 1 afternoon | 33.1 score on a scale | Standard Deviation 30.9 |
| Dexmedetomidine | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 2 evening | 54.9 score on a scale | Standard Deviation 36.3 |
| Dexmedetomidine | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 4 evening | 44.1 score on a scale | Standard Deviation 39.7 |
| Dexmedetomidine | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 3 morning | 49.8 score on a scale | Standard Deviation 39.8 |
| Dexmedetomidine | Anxiety Rating Using the 100mm Vertical Visual Analog Scale | Day 5 evening | 39.6 score on a scale | Standard Deviation 25.6 |
Comparison: We estimated the power for multilevel models approximating our study design. A sample size of 95 patients per arm, 190 total (at a minimum 7 data collection points for each, resulting in \~1,050 observations) will have greater than 80% power to detect small to moderate effects (i.e., 0.11 or greater) in between-group differences in anxiety, delirium, and duration of mechanical ventilation at alpha = .05 for all proposed models.p-value: 0.3Generalized estimating equations
p-value: 0.9858Generalized Estimating equations
Primary
Duration of Mechanical Ventilatory Support After Study Enrollment
Duration of time (hours) patients received mechanical ventilatory support after randomization to either Control or dexmedetomidine self-management of sedative therapy to extubation.
Time frame: 7 days
Population: Includes all patients enrolled who were randomized using an Intention to treat analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Duration of Mechanical Ventilatory Support After Study Enrollment | 68.7 hours | Standard Deviation 58.2 |
| Dexmedetomidine | Duration of Mechanical Ventilatory Support After Study Enrollment | 50.3 hours | Standard Deviation 52.8 |
p-value: 0.02t-test, 1 sided
Primary
Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU)
Confusion Assessment Method-ICU (CAM-ICU) used to assess for the presence (CAM-ICU+) or absence (CAM-ICU-) of delirium at each assessment.
Time frame: 7 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) | Study entry CAM-ICU+ | 15 participants CAM-ICU+ |
| Control | Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) | Day #4 CAM-ICU+ | 2 participants CAM-ICU+ |
| Control | Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) | Day #5 CAM-ICU+ | 2 participants CAM-ICU+ |
| Control | Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) | Day #6 CAM-ICU+ | 0 participants CAM-ICU+ |
| Control | Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) | Day #1 CAM-ICU+ | 14 participants CAM-ICU+ |
| Control | Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) | Day #2 CAM-ICU+ | 9 participants CAM-ICU+ |
| Control | Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) | Day #3 CAM-ICU+ | 8 participants CAM-ICU+ |
| Control | Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) | Day #7 CAM-ICU+ | 0 participants CAM-ICU+ |
| Dexmedetomidine | Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) | Day #7 CAM-ICU+ | 2 participants CAM-ICU+ |
| Dexmedetomidine | Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) | Day #3 CAM-ICU+ | 3 participants CAM-ICU+ |
| Dexmedetomidine | Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) | Day #1 CAM-ICU+ | 10 participants CAM-ICU+ |
| Dexmedetomidine | Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) | Day #4 CAM-ICU+ | 2 participants CAM-ICU+ |
| Dexmedetomidine | Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) | Day #6 CAM-ICU+ | 4 participants CAM-ICU+ |
| Dexmedetomidine | Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) | Day #5 CAM-ICU+ | 2 participants CAM-ICU+ |
| Dexmedetomidine | Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) | Day #2 CAM-ICU+ | 5 participants CAM-ICU+ |
| Dexmedetomidine | Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) | Study entry CAM-ICU+ | 7 participants CAM-ICU+ |
p-value: 0.97Generalized estimating equations
p-value: 0.5647Generalized estimating equations
Secondary
Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients.
Sedation Frequency is the number of individual intravenous (IV) sedative medication(s) doses administered to patients over each 24-hour day of lorazepam, midazolam, propofol, morphine, hydromorphone, dexmedetomidine, fentanyl, haloperidol, ketamine. Sedation frequency ranges from 0-216 with a higher number indicating more frequent receipt of a sedative medication(s).
Time frame: Daily Sedation Frequency over a 7-day ICU study protocol period
Population: Patients exit the study at various times over the 7-day ICU study period leading to a different number of patients available for analysis on each ICU study day.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #4 sedation frequency | 25.0 count of sedative medication doses | Standard Deviation 16.3 |
| Control | Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #5 sedation frequency | 25.9 count of sedative medication doses | Standard Deviation 17.9 |
| Control | Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Study entry sedation frequency | 13.9 count of sedative medication doses | Standard Deviation 8 |
| Control | Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #1 sedation frequency | 24.6 count of sedative medication doses | Standard Deviation 15.1 |
| Control | Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #2 sedation frequency | 24.3 count of sedative medication doses | Standard Deviation 17.2 |
| Control | Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #3 sedation frequency | 24.4 count of sedative medication doses | Standard Deviation 17.7 |
| Control | Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #6 sedation frequency | 23.5 count of sedative medication doses | Standard Deviation 19.3 |
| Control | Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #7 Sedation frequency | 14.9 count of sedative medication doses | Standard Deviation 14.2 |
| Dexmedetomidine | Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #6 sedation frequency | 27.3 count of sedative medication doses | Standard Deviation 10.9 |
| Dexmedetomidine | Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #3 sedation frequency | 24.3 count of sedative medication doses | Standard Deviation 14.1 |
| Dexmedetomidine | Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #4 sedation frequency | 30.2 count of sedative medication doses | Standard Deviation 14.8 |
| Dexmedetomidine | Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Study entry sedation frequency | 13.5 count of sedative medication doses | Standard Deviation 7.3 |
| Dexmedetomidine | Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #5 sedation frequency | 32.5 count of sedative medication doses | Standard Deviation 19 |
| Dexmedetomidine | Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #1 sedation frequency | 22.9 count of sedative medication doses | Standard Deviation 13.5 |
| Dexmedetomidine | Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #7 Sedation frequency | 16.0 count of sedative medication doses | Standard Deviation 10.2 |
| Dexmedetomidine | Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #2 sedation frequency | 25.0 count of sedative medication doses | Standard Deviation 15.5 |
Secondary
Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients.
Sedation intensity combines the number of sedative doses and the dose amount of any of 9 intravenous (IV) sedative medications (lorazepam, midazolam, propofol, morphine, hydromorphone, dexmedetomidine, fentanyl, haloperidol, ketamine) recorded in the electronic health record, summarized over all patients and time periods each day to obtain medians and quartiles. Each of the 9 sedative drugs administered during each 4-hr period is then assigned a ranking: 0 for drug not used, 1 for the bottom quartile, 2 for the second quartile, 3 for the third, and 4 for the fourth. A score is determined by summing for the 24-hr day over the 6, 4-hour blocks to produce a daily Sedation Intensity Score from 0-36, higher score more intense dosing received of sedative medications.
Time frame: Daily Sedation intensity over a 7-day ICU study protocol period
Population: Patients exit the study at various times over the 7-day ICU study period leading to a different number of patients available for analysis on each ICU study day.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #5 sedation intensity | 17.9 score on a scale | Standard Deviation 15.2 |
| Control | Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #6 sedation intensity | 16.9 score on a scale | Standard Deviation 18.8 |
| Control | Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #7 sedation intensity | 10.8 score on a scale | Standard Deviation 13.8 |
| Control | Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Study entry sedation intensity | 10.2 score on a scale | Standard Deviation 6.6 |
| Control | Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #1 sedation intensity | 17.3 score on a scale | Standard Deviation 12 |
| Control | Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #2 sedation intensity | 17.4 score on a scale | Standard Deviation 13 |
| Control | Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #3 sedation intensity | 17.5 score on a scale | Standard Deviation 14.2 |
| Control | Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #4 sedation intensity | 17.5 score on a scale | Standard Deviation 13.3 |
| Dexmedetomidine | Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #4 sedation intensity | 24.2 score on a scale | Standard Deviation 12.7 |
| Dexmedetomidine | Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #2 sedation intensity | 20.7 score on a scale | Standard Deviation 15.8 |
| Dexmedetomidine | Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #5 sedation intensity | 25.7 score on a scale | Standard Deviation 18.9 |
| Dexmedetomidine | Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #7 sedation intensity | 13.5 score on a scale | Standard Deviation 6.2 |
| Dexmedetomidine | Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #3 sedation intensity | 19.8 score on a scale | Standard Deviation 13.1 |
| Dexmedetomidine | Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Study entry sedation intensity | 9.1 score on a scale | Standard Deviation 6.9 |
| Dexmedetomidine | Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #6 sedation intensity | 22.8 score on a scale | Standard Deviation 10.6 |
| Dexmedetomidine | Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. | Day #1 sedation intensity | 16.6 score on a scale | Standard Deviation 13.1 |
p-value: 0.37GEE
Secondary
Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS)
The Richmond Agitation-Sedation Scale (RASS) was used to assess the level of alertness and agitation in enrolled patients. Scores range from -5 to +4. RASS 0/zero indicates alert and calm patient. Negative scores (-1 to -5) indicate increasing level of sedation with -5 indicating unarousable. Positive scores indicate increasing agitation (+1 to +4) with +4 indicating a combative patient. For enrolled study patients, RASS score -2 (light sedation) to +1 (restless) was considered in range. We report here the total number of patients assessed as outside the desirable range of RASS score -5 to -3 and +2 to +4 by each ICU study day.
Time frame: 7 days
Population: Not all patients were available for RASS assessment at each time point as some patients were extubated and completed the study, or were withdrawn or died.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #2 : Number of patients assessed | 42 Participants |
| Control | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #5 : Number of patients assessed | 20 Participants |
| Control | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #5 : Number of patients out of range | 2 Participants |
| Control | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #1 : Number of patients assessed | 65 Participants |
| Control | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #1 : Number of patients out of range | 12 Participants |
| Control | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #2 : Number of patients out of range | 7 Participants |
| Control | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #3 : Number of patients assessed | 36 Participants |
| Control | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #3 : Number of patients out of range | 6 Participants |
| Control | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #4 : Number of patients assessed | 27 Participants |
| Control | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #4 : Number of patients out of range | 2 Participants |
| Control | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #6 : Number of patients assessed | 17 Participants |
| Control | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #6 : Number of patients out of range | 1 Participants |
| Control | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #7 : Number of patients assessed | 14 Participants |
| Control | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #7 : Number of patients out of range | 1 Participants |
| Dexmedetomidine | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #7 : Number of patients assessed | 20 Participants |
| Dexmedetomidine | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #2 : Number of patients out of range | 5 Participants |
| Dexmedetomidine | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #3 : Number of patients out of range | 3 Participants |
| Dexmedetomidine | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #4 : Number of patients assessed | 12 Participants |
| Dexmedetomidine | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #6 : Number of patients out of range | 3 Participants |
| Dexmedetomidine | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #4 : Number of patients out of range | 4 Participants |
| Dexmedetomidine | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #1 : Number of patients assessed | 68 Participants |
| Dexmedetomidine | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #5 : Number of patients assessed | 12 Participants |
| Dexmedetomidine | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #1 : Number of patients out of range | 5 Participants |
| Dexmedetomidine | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #2 : Number of patients assessed | 32 Participants |
| Dexmedetomidine | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #5 : Number of patients out of range | 3 Participants |
| Dexmedetomidine | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #7 : Number of patients out of range | 1 Participants |
| Dexmedetomidine | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #3 : Number of patients assessed | 22 Participants |
| Dexmedetomidine | Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) | Day #6 : Number of patients assessed | 10 Participants |
p-value: 0.39Generalized estimating equation
Other Pre-specified
Comparison of Post-ICU Physical Status Using the Katz Activities of Daily Living Scale
Physical status will be assessed by the Katz Activities of Daily Living scale to assess basic physical abilities like bathing, feeding with 6 questions. Higher scores of 6 indicates the individual is independent, whereas a score of 0 indicates the individual is very dependent.
Time frame: Independence in activities of daily living at 3 months and 6 months after hospital discharge over the telephone
Population: Different number of patients responded to the telephone call at each time point~.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Comparison of Post-ICU Physical Status Using the Katz Activities of Daily Living Scale | 3 months after discharge | 5.1 score on a scale | Standard Deviation 1.8 |
| Control | Comparison of Post-ICU Physical Status Using the Katz Activities of Daily Living Scale | 6 months after discharge | 5.5 score on a scale | Standard Deviation 1.2 |
| Dexmedetomidine | Comparison of Post-ICU Physical Status Using the Katz Activities of Daily Living Scale | 3 months after discharge | 5.6 score on a scale | Standard Deviation 1 |
| Dexmedetomidine | Comparison of Post-ICU Physical Status Using the Katz Activities of Daily Living Scale | 6 months after discharge | 5.6 score on a scale | Standard Deviation 1.1 |
p-value: 0.17t-test, 1 sided
p-value: 0.81t-test, 1 sided
Other Pre-specified
Comparison of Post-ICU Psychological Well-being Status Using the Patient Health Questionnaire-9
Psychological well-being will be assessed by the Patient Health Questionnaire (PHQ-9) is a 9-item tool that tracks symptoms of major depression. Scores range from 9-36, with higher scores indicating altered psychological well-being.
Time frame: 3 and 6 months after ICU discharge over the telephone
Population: 3 month PHQ-9
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Comparison of Post-ICU Psychological Well-being Status Using the Patient Health Questionnaire-9 | 3 months after discharge | 23.0 score on a scale | Standard Deviation 4.3 |
| Control | Comparison of Post-ICU Psychological Well-being Status Using the Patient Health Questionnaire-9 | 6 months after discharge | 23.5 score on a scale | Standard Deviation 3.8 |
| Dexmedetomidine | Comparison of Post-ICU Psychological Well-being Status Using the Patient Health Questionnaire-9 | 3 months after discharge | 22.1 score on a scale | Standard Deviation 5.2 |
| Dexmedetomidine | Comparison of Post-ICU Psychological Well-being Status Using the Patient Health Questionnaire-9 | 6 months after discharge | 23.3 score on a scale | Standard Deviation 4.1 |
p-value: 0.47t-test, 1 sided
p-value: 0.82t-test, 1 sided
Other Pre-specified
Comparison of Post-ICU Psychological Well-being Status Using the Posttraumatic Stress Disorder Checklist Event Specific (PCL) Scale
Psychological well-being will be assessed with the Posttraumatic Stress Disorder Checklist Event Specific (PCL) to measure symptoms of posttraumatic stress disorder after a stressful life experience of ICU admission. Scores range from 17-85 with higher scores indicating being symptomatic for posttraumatic stress.
Time frame: 3 months and 6 months after ICU discharge over the telephone
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Comparison of Post-ICU Psychological Well-being Status Using the Posttraumatic Stress Disorder Checklist Event Specific (PCL) Scale | 23.8 score on a scale | Standard Deviation 7.4 |
| Dexmedetomidine | Comparison of Post-ICU Psychological Well-being Status Using the Posttraumatic Stress Disorder Checklist Event Specific (PCL) Scale | 27.7 score on a scale | Standard Deviation 15 |
Comparison: 3 months after ICU dischargep-value: 0.164t-test, 1 sided
Comparison: 6 months after ICU dischargep-value: 0.84t-test, 1 sided
Other Pre-specified
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Bodily Pain Domain
Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.
Time frame: 3 months after ICU discharge over the telephone bodily pain
Population: Bodily pain at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Bodily Pain Domain | 72.3 score on a scale | Standard Deviation 25.5 |
| Dexmedetomidine | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Bodily Pain Domain | 58.1 score on a scale | Standard Deviation 27.7 |
p-value: 0.03t-test, 1 sided
Other Pre-specified
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Bodily Pain Domain
Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.
Time frame: 6 months after ICU discharge over the telephone bodily pain
Population: Bodily pain at 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Bodily Pain Domain | 71.0 score on a scale | Standard Deviation 23.5 |
| Dexmedetomidine | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Bodily Pain Domain | 61.3 score on a scale | Standard Deviation 31.6 |
p-value: 0.17t-test, 1 sided
Other Pre-specified
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Emotional Well-being Domain
Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.
Time frame: 3 months after ICU discharge over the telephone Emotional Well-being
Population: Emotional well-being at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Emotional Well-being Domain | 83.5 score on a scale | Standard Deviation 14.7 |
| Dexmedetomidine | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Emotional Well-being Domain | 80.0 score on a scale | Standard Deviation 21.1 |
p-value: 0.43t-test, 1 sided
Other Pre-specified
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Emotional Well-being Domain
Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.
Time frame: 6 months after ICU discharge over the telephone Emotional Well-being
Population: Emotional well-being at 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Emotional Well-being Domain | 81.8 score on a scale | Standard Deviation 18.8 |
| Dexmedetomidine | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Emotional Well-being Domain | 83.5 score on a scale | Standard Deviation 15.5 |
p-value: 0.69t-test, 1 sided
Other Pre-specified
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 General Health Domain
Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.
Time frame: 3 months after ICU discharge over the telephone general health perceptions
Population: General health perceptions at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 General Health Domain | 52.3 score on a scale | Standard Deviation 21 |
| Dexmedetomidine | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 General Health Domain | 51.3 score on a scale | Standard Deviation 24.2 |
p-value: 0.85t-test, 1 sided
Other Pre-specified
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 General Health Domain
Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.
Time frame: 6 months after ICU discharge over the telephone general health perceptions
Population: General health perceptions at 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 General Health Domain | 52.7 score on a scale | Standard Deviation 22 |
| Dexmedetomidine | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 General Health Domain | 53.0 score on a scale | Standard Deviation 26.9 |
p-value: 0.95t-test, 1 sided
Other Pre-specified
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Personal or Emotional Health Domain
Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.
Time frame: 3 months after ICU discharge over the telephone Role Limitations due to Personal or Emotional Health
Population: Role limitations due to personal or emotional health at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Personal or Emotional Health Domain | 80.2 score on a scale | Standard Deviation 32.8 |
| Dexmedetomidine | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Personal or Emotional Health Domain | 76.2 score on a scale | Standard Deviation 33.8 |
p-value: 0.63t-test, 1 sided
Other Pre-specified
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Physical Function Domain
Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 (SF-36) at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.
Time frame: 3 months after ICU discharge over the telephone Physical Function Domain
Population: Physical Function at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Physical Function Domain | 45.4 score on a scale | Standard Deviation 29.9 |
| Dexmedetomidine | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Physical Function Domain | 53.8 score on a scale | Standard Deviation 29.9 |
p-value: 0.26t-test, 1 sided
Other Pre-specified
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Physical Function Domain
Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.
Time frame: 6 months after ICU discharge over the telephone Physical Function Domain
Population: Physical Function at 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Physical Function Domain | 57.0 score on a scale | Standard Deviation 26.6 |
| Dexmedetomidine | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Physical Function Domain | 58.6 score on a scale | Standard Deviation 30.7 |
p-value: 0.82t-test, 1 sided
Other Pre-specified
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Role Limitations Domain
Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.
Time frame: 6 months after ICU discharge over the telephone Role Limitations Domain due to Physical Health
Population: Role limitations due to physical health at 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Role Limitations Domain | 39.8 score on a scale | Standard Deviation 38 |
| Dexmedetomidine | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Role Limitations Domain | 44.2 score on a scale | Standard Deviation 39.8 |
p-value: 0.66t-test, 1 sided
Other Pre-specified
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Role Limitations Domain
Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.
Time frame: 3 months after ICU discharge over the telephone Role Limitations Domain due to Physical Health
Population: Role limitations due to physical health at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Role Limitations Domain | 22.4 score on a scale | Standard Deviation 32.8 |
| Dexmedetomidine | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Role Limitations Domain | 43.8 score on a scale | Standard Deviation 38.9 |
p-value: 0.018t-test, 1 sided
Other Pre-specified
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Socia Functioning Domain
Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.
Time frame: 6 months after ICU discharge over the telephone social functioning
Population: Social functioning at 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Socia Functioning Domain | 77.3 score on a scale | Standard Deviation 24.3 |
| Dexmedetomidine | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Socia Functioning Domain | 72.5 score on a scale | Standard Deviation 31.7 |
p-value: 0.5t-test, 1 sided
Other Pre-specified
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Social Functioning Domain
Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.
Time frame: 3 months after ICU discharge over the telephone social functioning
Population: Social functioning at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Social Functioning Domain | 76.4 score on a scale | Standard Deviation 22.6 |
| Dexmedetomidine | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Social Functioning Domain | 75.9 score on a scale | Standard Deviation 27.8 |
p-value: 0.94t-test, 1 sided
Other Pre-specified
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Using Personal or Emotional Health Domain
Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.
Time frame: 6 months after ICU discharge over the telephone Role Limitations due to Personal or Emotional Health
Population: Role limitations due to personal or emotional health at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Using Personal or Emotional Health Domain | 78.9 score on a scale | Standard Deviation 34.4 |
| Dexmedetomidine | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Using Personal or Emotional Health Domain | 71.4 score on a scale | Standard Deviation 37.2 |
p-value: 0.41t-test, 1 sided
Other Pre-specified
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Using the Energy/Fatigue Domain
Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.
Time frame: 6 months after ICU discharge over the telephone Energy/Fatigue
Population: Energy/fatigue at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Using the Energy/Fatigue Domain | 54.2 score on a scale | Standard Deviation 22.5 |
| Dexmedetomidine | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Using the Energy/Fatigue Domain | 53.8 score on a scale | Standard Deviation 20.2 |
p-value: 0.93t-test, 1 sided
Other Pre-specified
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Using the Energy/Fatigue Domain
Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.
Time frame: 3 months after ICU discharge over the telephone Energy/Fatigue Domain
Population: Energy/fatigue at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Using the Energy/Fatigue Domain | 54.3 score on a scale | Standard Deviation 19.2 |
| Dexmedetomidine | Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Using the Energy/Fatigue Domain | 43.6 score on a scale | Standard Deviation 26.7 |
p-value: 0.06t-test, 1 sided