Combining Objective and Subjective Sedation Assessment Tools

NCT ID: NCT00734409

Last Updated: 2013-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2011-07-31

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.

Conditions

Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RASS plus (BIS)

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

Group Type: EXPERIMENTAL

Bispectral Index (BIS) Monitor

Intervention Type: DEVICE

BIS monitoring in addition to RASS assessments

RASS only

Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bispectral Index (BIS) Monitor

BIS monitoring in addition to RASS assessments

Intervention Type: DEVICE

Other Intervention Names

Richmond agitation sedation scale; neurofunction monitor

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

DaiWai M Olson, PhD RN

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Health System

Durham, North Carolina, United States

Countries

United States

Other Identifiers

DUHS parent 3930938

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PRO00002117

Identifier Type: -

Identifier Source: org_study_id