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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01997931




Registration number
NCT01997931
Ethics application status
Date submitted
9/09/2005
Date registered
28/11/2013
Date last updated
28/11/2013

Titles & IDs
Public title
The Impact of Bispectral Index Monitoring on Sedation Administration in Mechanically Ventilated Patients
Scientific title
The Impact of Bispectral Index Monitoring on Sedation Administration in Mechanically Ventilated Patients
Secondary ID [1] 0 0
111/04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intensive Care 0 0
Mechanically Ventilated Patients 0 0
Sedated Patients 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Bispectral Index Sedation monitor

Treatment: Devices: Bispectral Index Sedation monitor
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Optimised sedation management for patients through the use of BIS monitoring.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Reduction in mechanical ventilation time.
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Reduced length of stay in the intensive care unit.
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
- Intubated and ventilated for at least 24 hours

- Sedated on morphine and midazelam infusions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Intracranial injury

- Status epilepticus

- Facial Burns

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2005
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
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. 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01997931
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Cindy A Weatherburn
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries