Critical Illness
Conditions
Keywords
Mechanical ventilation, Human, conscious sedation, bispectral index, monitoring, critical care, propofol
Brief summary
The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the Richmond Agitation Sedation Scale will give better assessment of a subject's level of sedation.
Detailed description
Patients in the intensive care unit (ICU) who require a ventilator to help them breathe also require sedation in order to keep them comfortable and prevent injury. The national guidelines for sedation management include a daily interruption of sedation performed once each morning. To determine the amount of sedation needed, the current standard practice is to use a system called the Richmond Agitation-Sedation Scale (RASS). The patient is stimulated by calling their name or by tapping their shoulder until the patient's responses indicate that a satisfactory level of sedation has been achieved. The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the RASS will give better assessment of a subject's level of sedation. The BIS monitor is a sensor strip taped to the forehead and attached to a device that reads electrical activity from the brain. It is approved by the U.S. Food and Drug Administration (FDA) for monitoring patients under sedation.
Interventions
DEVICEBispectral Index (BIS) Monitor
BIS monitoring in addition to RASS assessments
Sponsors
Medtronic - MITG
Duke University
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
* patient in the ICU * continuous IV sedation with propofol midazolam or dexmedetomidine * age \> 18 * expected to require mechanical ventilation for \>=48 hours
Exclusion criteria
* prisoners * no available space on forehead * continuous electroencephalography(EEG) monitoring * bifrontal brain injury * barbiturate coma therapy * known hypersensitivity to study medications * high risk for ethanol (ETOH) withdrawal * resuscitation from cardiac arrest without recovery of mental status * moribund clinical state (death expected within 48 hours)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Sedative Use | Intensive Care Unit (ICU) stay through discharge | The mean amount of propofol used on each patient while the patient was in the ICU and receiving mechanical ventilation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unplanned Self-device Removal Events | ICU stay through discharge | The number of unplanned self-device removal events that took place during the study period. |
| Mean Days on Mechanical Ventilation | ICU stay- through discharge | The mean number of days that the patients were on mechanical ventilation. |
Countries
United States
Participant flow
Recruitment details
Patients were in the Medical ICU or Neuro ICU at Duke University Hospital or the mixed ICU at Durham Regional. If patients met all inclusion criteria and no exclusion criteria, the attending was asked if patient's legally authorized representative (LAR) could be approached for consent. Enrollment started May of 2008 and closed April of 2011.
Pre-assignment details
Patients were only excluded from the trial after consent and prior to randomization if they no longer met inclusion criteria, for instance the medical team decided to remove sedatives.
Participants by arm
| Arm | Count |
|---|---|
| RASS Plus BIS Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring. | 155 |
| RASS Only Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution | 145 |
| Total | 300 |
Baseline characteristics
| Characteristic | RASS Plus BIS | RASS Only | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 53 Participants | 46 Participants | 99 Participants |
| Age, Categorical Between 18 and 65 years | 102 Participants | 99 Participants | 201 Participants |
| Age Continuous | 53.95 years STANDARD_DEVIATION 18.15 | 57.7 years STANDARD_DEVIATION 15.3 | 55.78 years STANDARD_DEVIATION 16.91 |
| Region of Enrollment United States | 155 participants | 145 participants | 300 participants |
| Sex: Female, Male Female | 76 Participants | 71 Participants | 147 Participants |
| Sex: Female, Male Male | 79 Participants | 74 Participants | 153 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 155 | 1 / 145 |
| serious Total, serious adverse events | 0 / 155 | 0 / 145 |
Outcome results
Primary
Mean Sedative Use
The mean amount of propofol used on each patient while the patient was in the ICU and receiving mechanical ventilation.
Time frame: Intensive Care Unit (ICU) stay through discharge
Population: All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RASS Plus BIS | Mean Sedative Use | 13.35 ml/hour | Standard Deviation 11.79 |
| RASS Only | Mean Sedative Use | 15.54 ml/hour | Standard Deviation 11.88 |
Secondary
Mean Days on Mechanical Ventilation
The mean number of days that the patients were on mechanical ventilation.
Time frame: ICU stay- through discharge
Population: All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RASS Plus BIS | Mean Days on Mechanical Ventilation | 7.43 Days | Standard Deviation 8.32 |
| RASS Only | Mean Days on Mechanical Ventilation | 6.85 Days | Standard Deviation 12.57 |
Secondary
Unplanned Self-device Removal Events
The number of unplanned self-device removal events that took place during the study period.
Time frame: ICU stay through discharge
Population: All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RASS Plus BIS | Unplanned Self-device Removal Events | 0 Event |
| RASS Only | Unplanned Self-device Removal Events | 1 Event |