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Trial registered on ANZCTR

Trial ID
Ethics application status
Date submitted
Date registered
Date last updated
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
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
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 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 461 0
Self funded/Unfunded
Name [1] 461 0
Address [1] 461 0
Country [1] 461 0
Primary sponsor type
The Intensive Care Unit of The Royal Melbourne Hospital
Secondary sponsor category [1] 374 0
Name [1] 374 0
Address [1] 374 0
Country [1] 374 0

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

Brief summary
Trial website
Trial related presentations / publications
Public notes

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
Country 9496 0
Phone 9496 0
+61 3 93427881
Fax 9496 0
Email 9496 0
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
Phone 424 0
+61 3 99257423
Fax 424 0
Email 424 0