Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000265673
Ethics application status
Approved
Date submitted
30/08/2005
Date registered
2/09/2005
Date last updated
2/09/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial of an Expert Weaning System (SmartcareTM) versus Usual Ventilatory Management in Critical Illness
Scientific title
A Randomised Controlled Trial of an Expert Weaning System (SmartcareTM) versus Usual Ventilatory Management in Critical Illness
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Weaning from ventilation 352 0
Condition category
Condition code
Other 412 412 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
Patients receiving mechanical ventilation for greater than 24 hours who meet the eligibility criteria will be randomised to receive weaning either by the usual care methods existing in the unit or via the SmartcareTM expert weaning system available on the Drager XL ventilators until they are ready for extubation.
Intervention code [1] 307 0
Treatment: Devices
Comparator / control treatment
Usual care
Control group
Active

Outcomes
Primary outcome [1] 472 0
Time to readiness for separation (extubation)
Timepoint [1] 472 0
Secondary outcome [1] 1021 0
Time to extubation (total duration of ventilation)
Timepoint [1] 1021 0
Secondary outcome [2] 1022 0
Weaning duration
Timepoint [2] 1022 0
Secondary outcome [3] 1023 0
Duration of ICU stay
Timepoint [3] 1023 0
Secondary outcome [4] 1024 0
Duration of hospital stay
Timepoint [4] 1024 0
Secondary outcome [5] 1025 0
Rate of reintubation
Timepoint [5] 1025 0
Secondary outcome [6] 1026 0
Use of non-invasive ventilation post extubation
Timepoint [6] 1026 0

Eligibility
Key inclusion criteria
Patient ventilated on non-spontaneous mode for 24 hoursPaO2/FiO2 > 150 or SaO2 90% with FiO2 .9PEEP 8cm H2OHemodynamically stable (Noradrenaline or Adrenaline less than 1 mg/hr)Body Temperature 36-39° CGlasgow coma score >4Stable neurological statusNo immediate requirements for transport or surgeryPass 30-minute pressure support testSmartcareTM enabled ventilator available for use.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with central nervous system disorders (e.g. stroke meningitis, cardiac arrest with neurologic sequelae) or neuromuscular disease (Guillain-Barre syndrome, myasthenia gravis).

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)
Numbered envelopes provided by The Statistical Consulting centre of THe University of Melbourne
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence will be generated by THe Statistical Consulting Centre of The University of Melbourne
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
222
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 461 0
Self funded/Unfunded
Name [1] 461 0
Country [1] 461 0
Primary sponsor type
Hospital
Name
The Intensive Care Unit of The Royal Melbourne Hospital
Address
Country
Australia
Secondary sponsor category [1] 374 0
None
Name [1] 374 0
Nil
Address [1] 374 0
Country [1] 374 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1434 0
The Melbourne Health HREC
Ethics committee address [1] 1434 0
Ethics committee country [1] 1434 0
Australia
Date submitted for ethics approval [1] 1434 0
Approval date [1] 1434 0
Ethics approval number [1] 1434 0

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

Contacts
Principal investigator
Name 36009 0
Address 36009 0
Country 36009 0
Phone 36009 0
Fax 36009 0
Email 36009 0
Contact person for public queries
Name 9496 0
Dr Jeffrey Presneill
Address 9496 0
Intensive Care Unit
Royal Melbourne Hospital
Grattan St
Parkville VIC 3050
Australia
Country 9496 0
Australia
Phone 9496 0
+61 3 93427881
Fax 9496 0
Email 9496 0
[email protected]
Contact person for scientific queries
Name 424 0
Ms Louise Rose
Address 424 0
Intensive Care Unit
Royal Melbourne Hospital
Grattan St
Parkville VIC 3050
Country 424 0
Australia
Phone 424 0
+61 3 99257423
Fax 424 0
Email 424 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.