Combining Objective and Subjective Sedation Assessment Tools

Not Applicable

Completed

• Conditions: Critical Illness
• Interventions: Device: Bispectral Index (BIS) Monitor

• Registration Number: NCT00734409
• Lead Sponsor: Duke University

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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Primary Completion: 2011-04
• Study Completion: 2011-07
• Status Verified: 2012-08
• Results First Submitted: 2012-08-10
• Results First Submitted QC: 2012-08-10
• Results First Posted: 2012-09-11
• Last Update Submitted: 2013-03-21
• Last Update Posted: 2013-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RASS plus (BIS)	Bispectral Index (BIS) Monitor	Participants in this arm will receive sedation assessment with the RASS scale augmented with Bispectral Index (BIS) Monitor

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States