Combining Objective and Subjective Sedation Assessment Tools (COST_2)

Combining Objective and Subjective Sedation Assessment Tools - Second Study

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Device: Bispectral Index (BIS) Monitor

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Medtronic - MITG
• Investigators: Principal Investigator: DaiWai M Olson, PhD RN, Duke University

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: June 3, 2008
• First Submitted That Met QC Criteria: August 13, 2008
• First Posted (Estimate): August 14, 2008

Study Record Updates

• Last Update Posted (Estimate): March 29, 2013
• Last Update Submitted That Met QC Criteria: March 21, 2013
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: critical care; Human; propofol; Mechanical ventilation; bispectral index; conscious sedation; monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: PRO00002117; DUHS parent 3930938 (Other Grant/Funding Number: Covidien)