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The SOMNUS Study: Sedative Optimization Via Monitoring Neurological Status

NCT00469482 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-03-08

No results posted yet for this study

Summary

A combined strategy of Richmond Agitation and Sedation Scale (RASS) clinical targeting plus bispectral index (BIS) guided sedation in mechanically ventilated, critically ill patients will decrease time on mechanical ventilation, decrease the duration of intensive care unit (ICU) delirium and coma, and will improve subacute neurocognitive function when compared to sedation guided by RASS targeting alone.

Conditions

Interventions

OTHER

Sedation,RASS Targeted plus BIS Monitoring

Providing patient sedation utilizing standard of care methods (RASS) plus BIS monitoring

OTHER

Sedation, RASS Targeted

Patient sedation utilizing standard of care methods (RASS targeted)

Sponsors & Collaborators

  • Medtronic - MITG

    collaborator INDUSTRY

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Wes Ely, MD · Vanderbilt Universtiy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-10-31
Completion
2016-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00469482 on ClinicalTrials.gov