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Trial registered on ANZCTR


Registration number
ACTRN12606000141549
Ethics application status
Approved
Date submitted
16/04/2006
Date registered
24/04/2006
Date last updated
19/08/2008
Type of registration
Retrospectively registered

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
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mechanically ventilated intensive care unit (ICU) patients receiving sedative drug infusions 1110 0
Condition category
Condition code
Other 1190 1190 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is designed as a prospective randomised control trial with parallel design. Participants randomised to the intervention group will receive bispectral index sedation (BIS) monitoring.

The bispectral index sedation monitor is derived from the electroencephalogram and provides a numeric value that represents cerebral activity. Nurses will be able to titrate and manage sedation based on an objective score (0- 100) that reflects the patients level of sedation. Patients randomised to recieve BIS monitoring will be continously monitored until they are extubated or a tracheostomy is performed. Patients randomised to the control intervention will recieve standard care and their sedative needs will be assessed and managed based on subjective sedation assessments. The control arm will continue until sedatives are no longer required.
Data collection will cease for all patients at the time of extubation or tracheostomy.
Both groups of participants will be managed by nurses with a range of general nursing and critical care nursing experience, and with differing levels of critical care training.
Intervention code [1] 985 0
Treatment: Devices
Comparator / control treatment
The control group will receive the standard Alfred Hospital intensive care unit sedation assessment and management. The control arm will continue until sedatives are no longer required.
Control group
Active

Outcomes
Primary outcome [1] 1604 0
The primary outcome measure will be mean sedation for each nursing shift
Timepoint [1] 1604 0
Mean sedation will be calculated at the end of each nursing shift. This will allow multiple data collection points per participant and repeated measures analysis.
Secondary outcome [1] 2903 0
Days of mechanical ventilation
Timepoint [1] 2903 0
Days. Measured at discharge from ICU.
Secondary outcome [2] 2904 0
Length of ICU stay (days)
Timepoint [2] 2904 0
Days. Measured at discharge from the ICU.

Eligibility
Key inclusion criteria
Intubated and mechanically ventilatedLikely to be ventilated for at least 12 hoursReceiving sedative infusion of morphine and midazolam.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intracranial injury, neurological disorders, 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)
Allocation was concealed by using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be undertaken using a computer generated random number list
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1301 0
University
Name [1] 1301 0
Australian College Critical Care Nursing
Address [1] 1301 0
PO Box 219
South Carlton
VICT 3053
Australia
Country [1] 1301 0
Australia
Primary sponsor type
Hospital
Name
Alfred Hospital
Address
89 Commercial Road
Melbourne
VIC 3004
Country
Australia
Secondary sponsor category [1] 1149 0
University
Name [1] 1149 0
LaTrobe Universtity
Address [1] 1149 0
Latrobe University (Bundora)
VICTORIA , 3086
Australia
Country [1] 1149 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2629 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 2629 0
Ethics committee country [1] 2629 0
Australia
Date submitted for ethics approval [1] 2629 0
Approval date [1] 2629 0
22/07/2004
Ethics approval number [1] 2629 0
111/04

Summary
Brief summary
This study is designed to assess the effectiveness of the Bispectral Index (BIS) monitor in helping nurses to decide if intensive care patient’s are receiving the right amount of sedation medication to keep them comfortable and asleep while they are connected to the ventilator. The BIS monitor is a non-invasive machine that measures electrical brain wave activity, and converts it into a number that indicates if patients are too awake or deeply unresponsive.

The study will be conducted in the Intensive Care Unit at the Alfred Hospital. This study is designed as a prospective randomised control trial with parallel design. This means that participants’ will be randomly allocated into either one of two groups – an intervention or control group. Participant’s randomised to the intervention group will receive BIS monitoring. The control group will receive standard ICU sedation assessment and management.

To determine if BIS monitoring is useful in ICU, information will be collected by auditing patient charts and determining the average amounts of sedation medication for each nursing shift. In addition, the years of critical care experience and critical care qualification will be recorded for each nurse managing patients recruited to the study.
Trial website
Trial related presentations / publications
Anaesthesia and Intensive Care 2007; 35: 204-208
Public notes

Contacts
Principal investigator
Name 35703 0
Address 35703 0
Country 35703 0
Phone 35703 0
Fax 35703 0
Email 35703 0
Contact person for public queries
Name 10174 0
Cindy Weatherburn
Address 10174 0
Alfred Hospital
89 Commercial Road
Melbourne VIC 3004
Country 10174 0
Australia
Phone 10174 0
61 3 90768801
Fax 10174 0
61 3 90762343
Email 10174 0
c.weatherburn@alfred.org.au
Contact person for scientific queries
Name 1102 0
Cindy Weatherburn
Address 1102 0
Alfred Hospital
89 Commercial Road
Melbourne VIC 3004
Country 1102 0
Australia
Phone 1102 0
61 3 90768801
Fax 1102 0
61 3 90762343
Email 1102 0
c.weatherburn@alfred.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary