NCT01997931

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2004

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
8.2 years until next milestone

First Posted

Study publicly available on registry

November 28, 2013

Completed
Last Updated

November 28, 2013

Status Verified

November 1, 2013

Enrollment Period

9 months

First QC Date

September 9, 2005

Last Update Submit

November 25, 2013

Conditions

Intensive CareMechanically Ventilated PatientsSedated Patients

Keywords

bispectral indexsedationintensive caremechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Optimised sedation management for patients through the use of BIS monitoring.

Secondary Outcomes (2)

  • Reduction in mechanical ventilation time.

  • Reduced length of stay in the intensive care unit.

Interventions

Bispectral Index Sedation monitorDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Intubated and ventilated for at least 24 hours
  • Sedated on morphine and midazelam infusions

You may not qualify if:

  • Intracranial injury
  • Status epilepticus
  • Facial Burns

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Study Officials

  • Cindy A Weatherburn

    The Alfred

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

November 28, 2013

Study Start

September 1, 2004

Primary Completion

June 1, 2005

Study Completion

July 1, 2005

Last Updated

November 28, 2013

Record last verified: 2013-11

Locations

AU(1)