Combining Observational and Physiologic Sedation Assessment Tools

Brain Injury Clinical Trial

— COST  

Official title:

Combining Observational and Physiologic Sedation Assessment Tools

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00538369
• Other study ID #: Pro00008519
• Secondary ID: 8771-06 - 8RO
• Status: Terminated
• Phase: Phase 4
• First received: October 1, 2007
• Last updated: October 11, 2015
• Start date: November 2006
• Est. completion date: September 2007

Study information

• Verified date: October 2007
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

When a physiologic tool to measure the patient's hypnotic state is added to current practice tools is there a decrease in the amount of drug the patient receives.

Description:

The purposes of this study were to examine the effect of combining a physiologic measure of consciousness (BIS) with observational assessment of sedation (Ramsay) on infused sedation drug volumes, undersedation events, and the recovery time to arouse from sedation, in a group of neurocritically ill patients. During a 12-hour data collection period, patients received sedation assessment and management with either the current standard of care (sedation assessment with the Ramsay scale), or the standard of care plus the addition of physiologic data from BIS monitoring. Planned research questions explored how BIS monitoring impacts short-term sedation-related outcomes.

Research Questions

• Is there less sedation drug use for patients when nurses monitor sedation with BIS augmentation of Ramsay than when nurses monitor patients with Ramsay alone?

• Is sedation assessment augmented by BIS use associated with a decreased time to wake-up (recovery time) when nurses are instructed to interrupt sedation and obtain a neurologic examination, compared to use of Ramsay alone?

• Are there differences in the number of events associated with undersedation (e.g., self-extubation) for patients assigned to BIS augmentation compared to patients assigned to Ramsay alone?

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult

• admitted with a neurological or neurosurgical diagnosis

• intubated and on mechanical ventilatory support

• receiving continuous sedation with propofol

• Glasgow Coma Score <12

Exclusion Criteria:

• bifrontal brain injury

• status epilepticus

• barbiturate coma therapy

• continuous benzodiazepine administration

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injury

Intervention

Other:
• Ramsay Scale
While receiving sedation, subjects will be monitored with the Ramsay scale

Device:
• Bispectral index monitor
While receiving sedation, subjects will receive BIS monitoring

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Medtronic - MITG, University of North Carolina

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	How much sedative was infused		length of stay
Secondary	How quickly the subject recovered from sedation		once
Secondary	The number of undersedation events		length of stay in ICU