Combining Objective and Subjective Sedation Assessment Tools (COST_2)

Duke University

Status: Completed

Conditions: Critical Illness

Treatments: Device: Bispectral Index (BIS) Monitor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00734409

DUHS parent 3930938 (Other Grant/Funding Number)

PRO00002117

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

RASS plus (BIS)

Experimental group

Description:

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

Treatment:

Device: Bispectral Index (BIS) Monitor

RASS only

No Intervention group

Description:

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