The Impact of Bispectral Index Monitoring on Sedation Administration in Mechanically Ventilated Patients

NCT01997931 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-11-28

No results posted yet for this study

Summary

This prospective randomised controlled trial was designed to assess the effectiveness of the Bispectral Index Sedation (BIS) monitor in supporting clinical, sedation management decisions in mechanically ventilated ICU patients.

The primary hypothesis for the study is that patients with Bispectral Index Sedation (BIS) monitoring will receive less sedation then those receiving standard sedation management.

The secondary hypotheses are:

1. Patients with BIS have fewer ventilation days than those receiving standard sedation management.
2. Level of sedation administered will differ according to the critical care experience and qualification of the nurse.

Conditions

  • Intensive Care
  • Mechanically Ventilated Patients
  • Sedated Patients

Interventions

DEVICE

Bispectral Index Sedation monitor

Sponsors & Collaborators

  • Bayside Health

    lead OTHER_GOV

Principal Investigators

  • Cindy A Weatherburn · The Alfred

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2005-06-30
Completion
2005-07-31

Countries

  • Australia

Study Locations

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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 NCT01997931 on ClinicalTrials.gov