Combining Observational and Physiologic Sedation Assessment Tools

NCT00538369 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2015-10-14

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University of North Carolina

    collaborator OTHER
  • Medtronic - MITG

    collaborator INDUSTRY
  • Duke University

    lead OTHER

Principal Investigators

  • DaiWai M Olson, PhD RN CCRN · Duke University

  • Suzanne M Thoyre, PhD RN · University of North Carolina, Chapel Hill

  • Carmelo Graffagnino, MD FRCPC · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Completion
2007-09-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00538369 on ClinicalTrials.gov