Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00202319




Registration number
NCT00202319
Ethics application status
Date submitted
14/09/2005
Date registered
20/09/2005
Date last updated
20/09/2005

Titles & IDs
Public title
Effectiveness of Sedation Management in an Australian Intensive Care Unit
Scientific title
Evaluating the Effectiveness of Protocol Directed Sedation Management With Non-Protocol Directed Sedation Management on Mechanically Ventilated Patients in an Australian Intensive Care Unit.
Secondary ID [1] 0 0
2001.102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiration Disorders 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Duration of Ventilation
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Length of stay
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Tracheostomy insertion rate
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Self extubation rate
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
* mechanically ventilated
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* cardiac surgery patients
* those patients readmitted to the ICU who had been on the study during a previous admission were excluded for any subsequent admissions.

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
NA
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
1/11/2001
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)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australian College of Critical Care Nurses
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
Abbott
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Tracey K Bucknall, RN PhD
Address 0 0
University of Melbourne
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

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

TypeCitations or Other Details
Journal Rose RL, Bucknall T. Staff perceptions on the use ... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00202319