Mechanical Ventilation, Respiratory Failure
Conditions
Keywords
Sedation, Mechanical Ventilation, Emergency Department, RASS
Brief summary
The ED-SED Pilot is a multicenter, prospective, before-and-after study conducted on 344 mechanically ventilated emergency department patients at three academic medical centers: Washington University in St. Louis School of Medicine (St. Louis, MO), Cooper Hospital of Rowan University (Camden, NJ), and University of Iowa Carver College of Medicine (Iowa City, IA). The overall goal is to assess the feasibility of implementing targeted sedation (in terms of sedation depth) for mechanically ventilated ED patients in order to reduce the incidence of unnecessary deep sedation and improve clinical outcomes.
Detailed description
The ED-SED Pilot is a multicenter, prospective, before-and-after study conducted on 344 mechanically ventilated ED patients at three academic medical centers. Patients in the before phase of the study will receive usual care after the initiation of mechanical ventilation. After 172 patients have been enrolled in the before phase, the investigators will begin educational initiatives to implement ED-based sedation protocols and order sets. The research team will educate providers on the importance of sedation protocols on patient outcome so that the existing protocols begin to be used effectively in the ED. This educational initiative will allow targeted sedation to be effectively used in the ED as well, allowing the intervention to be tested under real-world conditions. Participants in the after phase will also receive standard post-intubation care at the discretion of the treating team, though it will be after the educational initiative aimed at improving post-intubation sedation. In order to more effectively use sedation in the ED, the investigators will collect voluntary and anonymous surveys from ED nurses and physicians to assess the potential facilitators and barriers to adherence to guideline-recommended sedation.
Interventions
BEHAVIORALEducation
Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols.
OTHERStandard post intubation sedation practices
Usual care sedation provide in the ED
Sponsors
University of Iowa
Cooper University Health Care
National Heart, Lung, and Blood Institute (NHLBI)
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a prospective, before-and-after study, and there will be no randomization process.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Mechanical ventilation via an endotracheal tube. 2. Age ≥ 18 years.
Exclusion criteria
1. Acute neurologic injury (stroke, intracranial hemorrhage, traumatic brain injury, cardiac arrest, status epilepticus, fulminant hepatic failure). 2. Ongoing neuromuscular blockade. 3. Death or transition to comfort measures within 24 hours. 4. Transfer to another hospital from the ED. 5. Chronic/home mechanical ventilation. 6. Transfer directly from the ED to the operating room.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Recruitment | Through study completion, an average of 1 year | Count of eligible participants included in study |
| Percentage of Patients With Richmond Agitation-Sedation Scale (RASS) Scores in Deep Sedation Range | Up to 12 hours (during mechanical ventilation in the emergency department) | Deep sedation defined as RASS of -3 to -5 Measure of Sedation via RASS. Scale: +4 Combative, +3 Very agitated, +2 Agitated, +1 Restless, 0 Alert and Calm, -1 Drowsy, -2 Light sedation, -3 Moderate sedation, -4 Deep sedation, -5 Unarousable |
| Reliability of Richmond Agitation-Sedation Scale (RASS) Measurements During Routine Care in the ED | Up to 12 hours (during mechanical ventilation in the emergency department) | Interrater correlation coeficient. These were paired observations between study team members and ED nurses. It reflects the degree of agreement between independent observers. |
| Number of Participants With Adverse Events | Up to 12 hours (during mechanical ventilation in the emergency department) | Inadvertent extubation, inadvertent device removal (e.g. central venous catheter, urinary catheter), awareness with paralysis events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-free Days | Up to 28 days | To define, ventilator-free days equal: 1) 0 if patient dies within 28 days of mechanical ventilation; 2) 28 - x if successfully liberated from mechanical ventilation 'x' days after intubation; or 3) 0 if mechanical ventilation duration exceeds 28 days. |
| Mortality | Up to 28 days, or for the duration of hospitalization | Hospital mortality |
| ICU-free Days | Up to 28 days | To define, ICU-free days equal: 1) 0 if patient dies within 28 days of ICU admission; 2) 28 - x if successfully discharged from the ICU 'x' days after admission to the ICU; or 3) 0 if ICU length of stay exceeds 28 days. |
| Hospital-free Days | Up to 28 days | To define, hospital-free days equal: 1) 0 if patient dies within 28 days of hospital admission; 2) 28 - x if successfully discharged from the hospital 'x' days after admission to the hospital; or 3) 0 if hospital length of stay exceeds 28 days. |
| Number of Participants With Delirium | Up to 7 days | Delirium defined as being CAM-ICU positive as documented by bedside nurse during routine care. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Before Group Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation
Standard post intubation sedation practices: Usual care sedation provide in the ED | 196 |
| After Group Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED
Education: Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols. | 219 |
| Total | 415 |
Baseline characteristics
| Characteristic | Before Group | After Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical >=65 years | 74 Participants | 84 Participants | 158 Participants |
| Age, Categorical Between 18 and 65 years | 120 Participants | 134 Participants | 254 Participants |
| Age, Continuous | 57.9 years STANDARD_DEVIATION 18.4 | 57.4 years STANDARD_DEVIATION 18.3 | 57.6 years STANDARD_DEVIATION 18.3 |
| Race/Ethnicity, Customized Race Asian | 6 Participants | 4 Participants | 10 Participants |
| Race/Ethnicity, Customized Race Black | 71 Participants | 94 Participants | 165 Participants |
| Race/Ethnicity, Customized Race Hispanic | 14 Participants | 18 Participants | 32 Participants |
| Race/Ethnicity, Customized Race Other | 4 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Race White | 101 Participants | 102 Participants | 203 Participants |
| Region of Enrollment United States | 196 participants | 219 participants | 415 participants |
| Sex: Female, Male Female | 71 Participants | 90 Participants | 161 Participants |
| Sex: Female, Male Male | 125 Participants | 129 Participants | 254 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 40 / 196 | 22 / 219 |
| other Total, other adverse events | 0 / 196 | 0 / 219 |
| serious Total, serious adverse events | 8 / 196 | 11 / 219 |
Outcome results
Primary
Number of Participants With Adverse Events
Inadvertent extubation, inadvertent device removal (e.g. central venous catheter, urinary catheter), awareness with paralysis events
Time frame: Up to 12 hours (during mechanical ventilation in the emergency department)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Before Group | Number of Participants With Adverse Events | 8 Participants |
| After Group | Number of Participants With Adverse Events | 11 Participants |
Primary
Participant Recruitment
Count of eligible participants included in study
Time frame: Through study completion, an average of 1 year
Population: These numbers reflect the number of eligible participants who were included in the study for analysis (i.e. the final study population). As mentioned above in Participant Flow, there were 1771 participants assessed for eligibility and 1356 were not eligible for the study. Therefore, the overall number of participants analyzed (i.e. 415) relects this.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Before Group | Participant Recruitment | 196 Participants |
| After Group | Participant Recruitment | 219 Participants |
Primary
Percentage of Patients With Richmond Agitation-Sedation Scale (RASS) Scores in Deep Sedation Range
Deep sedation defined as RASS of -3 to -5 Measure of Sedation via RASS. Scale: +4 Combative, +3 Very agitated, +2 Agitated, +1 Restless, 0 Alert and Calm, -1 Drowsy, -2 Light sedation, -3 Moderate sedation, -4 Deep sedation, -5 Unarousable
Time frame: Up to 12 hours (during mechanical ventilation in the emergency department)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Before Group | Percentage of Patients With Richmond Agitation-Sedation Scale (RASS) Scores in Deep Sedation Range | 118 Participants |
| After Group | Percentage of Patients With Richmond Agitation-Sedation Scale (RASS) Scores in Deep Sedation Range | 85 Participants |
Primary
Reliability of Richmond Agitation-Sedation Scale (RASS) Measurements During Routine Care in the ED
Interrater correlation coeficient. These were paired observations between study team members and ED nurses. It reflects the degree of agreement between independent observers.
Time frame: Up to 12 hours (during mechanical ventilation in the emergency department)
Population: Reliability of RASS assessments was only assessed in the after group as an assurance that the protocol was being effectively implemented and RASS measured appropriately
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| After Group | Reliability of Richmond Agitation-Sedation Scale (RASS) Measurements During Routine Care in the ED | 0.88 ICC |
Secondary
Hospital-free Days
To define, hospital-free days equal: 1) 0 if patient dies within 28 days of hospital admission; 2) 28 - x if successfully discharged from the hospital 'x' days after admission to the hospital; or 3) 0 if hospital length of stay exceeds 28 days.
Time frame: Up to 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Before Group | Hospital-free Days | 14.3 days | Standard Deviation 10.1 |
| After Group | Hospital-free Days | 15.2 days | Standard Deviation 9.2 |
Secondary
ICU-free Days
To define, ICU-free days equal: 1) 0 if patient dies within 28 days of ICU admission; 2) 28 - x if successfully discharged from the ICU 'x' days after admission to the ICU; or 3) 0 if ICU length of stay exceeds 28 days.
Time frame: Up to 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Before Group | ICU-free Days | 18.1 days | Standard Deviation 10.4 |
| After Group | ICU-free Days | 20.8 days | Standard Deviation 8.7 |
Secondary
Mortality
Hospital mortality
Time frame: Up to 28 days, or for the duration of hospitalization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Before Group | Mortality | 40 Participants |
| After Group | Mortality | 22 Participants |
Secondary
Number of Participants With Delirium
Delirium defined as being CAM-ICU positive as documented by bedside nurse during routine care.
Time frame: Up to 7 days
Population: We recognize that the Overall Number of Participants Analyzed is not consistent with numbers provided in any of the rows in the Participant Flow module. The numbers analyzed for delirium reflect the fact that some patients either died or were discharged and therefore not eligible to be assessed for delirium during the time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Before Group | Number of Participants With Delirium | 63 Participants |
| After Group | Number of Participants With Delirium | 62 Participants |
Secondary
Ventilator-free Days
To define, ventilator-free days equal: 1) 0 if patient dies within 28 days of mechanical ventilation; 2) 28 - x if successfully liberated from mechanical ventilation 'x' days after intubation; or 3) 0 if mechanical ventilation duration exceeds 28 days.
Time frame: Up to 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Before Group | Ventilator-free Days | 19.9 days | Standard Deviation 10.6 |
| After Group | Ventilator-free Days | 22.0 days | Standard Deviation 9 |