Combining Observational and Physiologic Sedation Assessment Tools

Phase 4

Terminated

• Conditions: Brain Injury
• Interventions: Other: Ramsay Scale; Device: Bispectral index monitor

• Registration Number: NCT00538369
• Lead Sponsor: Duke University

Brief 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.

Detailed 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?

Study Timeline

• Study Start: 2006-11
• Study Completion: 2007-09
• Status Verified: 2007-10
• Study First Submitted: 2007-10-01
• Study First Submitted QC: 2007-10-01
• Study First Posted: 2007-10-02
• Last Update Submitted: 2015-10-11
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 67

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard + BIS	Bispectral index monitor	Subjects in the standard-of-care + BIS group will receive sedation assessment and monitoring using the Ramsay scale and values from the bispectral index (BIS) monitor.
standard-of-care	Ramsay Scale	The standard-of-care group will receive sedation assessment and monitoring with the Ramsay scale, which is the accepted tool at this university
standard + BIS	Ramsay Scale	Subjects in the standard-of-care + BIS group will receive sedation assessment and monitoring using the Ramsay scale and values from the bispectral index (BIS) monitor.

Primary Outcome Measures

Name	Time	Method
How much sedative was infused	length of stay

Secondary Outcome Measures

Name	Time	Method
The number of undersedation events	length of stay in ICU
How quickly the subject recovered from sedation	once

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States