Combining Objective and Subjective Sedation Assessment Tools

Critical Illness Clinical Trial

— COST_2  

Official title:

Combining Objective and Subjective Sedation Assessment Tools - Second Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00734409
• Other study ID #: PRO00002117
• Secondary ID: DUHS parent 3930
• Status: Completed
• Phase: N/A
• First received: June 3, 2008
• Last updated: March 21, 2013
• Start date: May 2008
• Est. completion date: July 2011

Study information

• Verified date: August 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness

Intervention

Device:
• Bispectral Index (BIS) Monitor
BIS monitoring in addition to RASS assessments

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Unplanned Self-device Removal Events	The number of unplanned self-device removal events that took place during the study period.	ICU stay through discharge	Yes
Secondary	Mean Days on Mechanical Ventilation	The mean number of days that the patients were on mechanical ventilation.	ICU stay- through discharge	No