Combining Observational and Physiologic Sedation Assessment Tools (COST)

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.

Study Overview

• Status: Terminated
• Conditions: Brain Injury
• Intervention / Treatment: Other: Ramsay Scale; Device: Bispectral index monitor

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 Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: standard-of-care; The standard-of-care group will receive sedation assessment and monitoring with the Ramsay scale, which is the accepted tool at this university	Other: Ramsay Scale; While receiving sedation, subjects will be monitored with the Ramsay scale; Other Names: Ramsay sedation scale
EXPERIMENTAL: standard + BIS; 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.	Other: Ramsay Scale; While receiving sedation, subjects will be monitored with the Ramsay scale; Other Names: Ramsay sedation scale; Device: Bispectral index monitor; While receiving sedation, subjects will receive BIS monitoring; Other Names: BIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
How much sedative was infused	length of stay

Secondary Outcome Measures

Outcome Measure	Time Frame
How quickly the subject recovered from sedation	once
The number of undersedation events	length of stay in ICU

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Medtronic - MITG; University of North Carolina
• Investigators: Study Chair: Suzanne M Thoyre, PhD RN, University of North Carolina, Chapel Hill; Study Director: Carmelo Graffagnino, MD FRCPC, Duke University

Publications and helpful links

General Publications

• Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Study Completion (ACTUAL): September 1, 2007

Study Registration Dates

• First Submitted: October 1, 2007
• First Submitted That Met QC Criteria: October 1, 2007
• First Posted (ESTIMATE): October 2, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): October 14, 2015
• Last Update Submitted That Met QC Criteria: October 11, 2015
• Last Verified: October 1, 2007

More Information

Terms related to this study

• Keywords: critical care; Bispectral index; Nursing; sedation assessment
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: Pro00008519; 8771-06 - 8RO