Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000158662
Ethics application status
Approved
Date submitted
12/08/2005
Date registered
15/08/2005
Date last updated
15/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
THE EFFECT OF AN ALGORITHM BASED SEDATION GUIDELINE ON THE DURATION OF MECHANICAL VENTILATION FOR INTENSIVE CARE PATIENTS IN AN AUSTRALIAN INTENSIVE CARE UNIT
Scientific title
THE EFFECTS OF AN ALGORITHM BASED SEDATION GUIDELINE ON THE DURATION OF MECHANICAL VENTILATION FOR INTENSIVE CARE PATIENTS IN AN AUSTRALIAN INTENSIVE CARE UNIT
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 253 0
Condition category
Condition code
Other 285 285 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
The intervention (a sedation guideline previously found to be beneficial) was tested in a quasi-experimental preintervention study (n=322). The study was conducted in two phases, a ten-month preintervention data collection phase (November 2002 to October 2003) was followed by a twelve-month postintervention phase (November 2003 to December 2004).
Intervention code [1] 180 0
None
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332 0
The primary aim of the study was to determine whether an algorithm based sedation guideline reduced duration of mechanical ventilation for ICU patients.
Timepoint [1] 332 0
Secondary outcome [1] 738 0
To determine whether the use of a sedation guideline improved the experience of recovery after ICU for mechanically ventilated patients, reflected by lower ETIC-7 scores.
Timepoint [1] 738 0
Secondary outcome [2] 739 0
To determine whether the use of a sedation guideline reduced the length of ICU stay
Timepoint [2] 739 0
Secondary outcome [3] 740 0
The incidence of unscheduled self-extubations
Timepoint [3] 740 0
Secondary outcome [4] 741 0
The rate of reintubation and the number of tracheostomies.
Timepoint [4] 741 0
Secondary outcome [5] 742 0
The effect of the study intervention on the costs of intravenous analgesic and sedative medications was also examined.
Timepoint [5] 742 0
Secondary outcome [6] 743 0
In addition the rate of adoption of the new practices of sedation scoring and use of a sedation guideline by bedside clinicians was explored.
Timepoint [6] 743 0

Eligibility
Key inclusion criteria
Research participants were selected on the basis of whether they were mechanically ventilated while they were in intensive care. Participants were eligible for inclusion if they were adults older than 17 years.
Minimum age
17 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were excluded if they: i) had a primary diagnosis of head injury or other neurological insult and where the aim of sedation was to reduce or minimise intracranial pressure and/or cerebral artery spasm.ii) were not expected to live for more than 24 hours after admission, e.g. patients who had a diagnosis of brain stem death or who were likely to require brain stem death tests.iii) had an explicit ventilation weaning goal on admission e.g. post operative coronary artery bypass graft patients recovering from general anaesthetic.iv) were likely to be ventilated for more than 21 days, e.g. patients with neurological conditions such as Guillain-Barre Syndrome and myasthenia gravis, and patients who had sustained a recent complete spinal cord lesion above cervical spine vertebra number five.v) had previously been enrolled in the study and were readmitted to the intensive care unit more than 72 hours after they were discharged. However for the purpose of this project patients who were readmitted within 72 hours were regarded as being in the same ICU admission.vi) had sustained a burn injury covering more than 15% of their body surface area.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Other
Other design features
pre and post
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/01/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
322
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 338 0
Self funded/Unfunded
Name [1] 338 0
Country [1] 338 0
Primary sponsor type
Individual
Name
Professor Sharon McKinley
Address
Country
Secondary sponsor category [1] 269 0
Individual
Name [1] 269 0
Miss Rosalind Elliott
Address [1] 269 0
Country [1] 269 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35769 0
Address 35769 0
Country 35769 0
Phone 35769 0
Fax 35769 0
Email 35769 0
Contact person for public queries
Name 9369 0
Miss Rosalind Elliott
Address 9369 0
Royal North Shore Hospital
St Leonards NSW 2065
Country 9369 0
Australia
Phone 9369 0
+61 2 99267853
Fax 9369 0
+61 2 94398418
Email 9369 0
[email protected]
Contact person for scientific queries
Name 297 0
Miss Rosalind Elliot
Address 297 0
Royal North Shore Hospital
St Leonards NSW 2065
Country 297 0
Australia
Phone 297 0
+61 2 99267853
Fax 297 0
+61 2 94398418
Email 297 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.