Combining Objective and Subjective Sedation Assessment Tools

Study Overview
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Brief Summary
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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
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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.

Official Title
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Combining Objective and Subjective Sedation Assessment Tools - Second Study

Conditions
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Critical Illness

Intervention / Treatment
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* Device: Bispectral Index (BIS) Monitor


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RASS plus (BIS)<br>Participants in this arm will receive sedation assessment with the RASS scale augmented with Bispectral Index (BIS) Monitor | Device: Bispectral Index (BIS) Monitor<br>* BIS monitoring in addition to RASS assessments<br>* Other names: neurofunction monitor;|
| No Intervention: RASS only<br>Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Sedative Use | The mean amount of propofol used on each patient while the patient was in the ICU and receiving mechanical ventilation. | Intensive Care Unit (ICU) stay through discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unplanned Self-device Removal Events | The number of unplanned self-device removal events that took place during the study period. | ICU stay through discharge | 
| Mean Days on Mechanical Ventilation | The mean number of days that the patients were on mechanical ventilation. | ICU stay- through discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical ventilation, Human, conscious sedation, bispectral index, monitoring, critical care, propofol