Combining Observational and Physiologic Sedation Assessment Tools

NCT00538369 | Terminated Phase 4 DMC

• 2 other identifiers: Pro000085198771-06 - 8RO
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injury

Keywords

Nursing; critical care; sedation assessment; Bispectral index

Outcome Measures

Primary Outcomes (1)

• How much sedative was infused

  length of stay

Secondary Outcomes (2)

• How quickly the subject recovered from sedation

  once

• The number of undersedation events

  length of stay in ICU

Study Arms (2)

standard-of-care

ACTIVE COMPARATOR

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

standard + BIS

EXPERIMENTAL

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; Device: Bispectral index monitor

Interventions

Ramsay Scale OTHER

While receiving sedation, subjects will be monitored with the Ramsay scale

Also known as: Ramsay sedation scale

standard + BIS; standard-of-care

Bispectral index monitor DEVICE

While receiving sedation, subjects will receive BIS monitoring

Also known as: BIS

standard + BIS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult
• admitted with a neurological or neurosurgical diagnosis
• intubated and on mechanical ventilatory support
• receiving continuous sedation with propofol
• Glasgow Coma Score \<12

You may not qualify if:

• bifrontal brain injury
• status epilepticus
• barbiturate coma therapy
• continuous benzodiazepine administration

Sponsors & Collaborators

• Duke University: lead
• University of North Carolina: collaborator
• Medtronic - MITG: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related 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. doi: 10.1136/bmj.2.5920.656.

  PMID: 4835444 BACKGROUND

MeSH Terms

Conditions

Brain Injuries

Interventions

Consciousness Monitors

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• DaiWai M Olson, PhD RN CCRN

  Duke University

  PRINCIPAL INVESTIGATOR

• Suzanne M Thoyre, PhD RN

  University of North Carolina, Chapel Hill

  STUDY CHAIR

• Carmelo Graffagnino, MD FRCPC

  Duke University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2007
• First Posted: October 2, 2007
• Study Start: November 1, 2006
• Study Completion: September 1, 2007
• Last Updated: October 14, 2015

Record last verified: 2007-10

Locations

US (1)