Trial Review

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
ACTRN12612001097831
Ethics application status
Approved
Date submitted
12/10/2012
Date registered
16/10/2012
Date last updated
16/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
PAV + VENTILATION TRIAL- A Randomised Controlled trial comparing Proportional Assist Ventilation (PAV+) ventilation and pressure support ventilation in patients eligible for spontaneous ventilation.
Scientific title
PAV + VENTILATION TRIAL- A Randomised Controlled trial comparing Proportional Assist Ventilation (PAV+) ventilation and pressure support ventilation in patients eligible for spontaneous ventilation
Secondary ID [1] 281383 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ventilated Patients in the intensive care unit are often difficult to wean and liberate from the ventilator.
A new mode of ventilation called PAV+ has advantages over Pressure Support ventilation and may facilitate patients weaning.The study will be a randomised trial comparing the above two modes of ventilation in patients suitable for weaning. 287615 0
Condition category
Condition code
Anaesthesiology 287945 287945 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who have been ventilated for > 48hrs and are suitable for spontaneous breathing will be randomised into either;
Arm 1.Proportional Assist Ventilation ( PAV+) ventilation or
Arm 2. Pressure Support ( PS) ventilation arm.
Once assigned to either the PAV+arm or PS arm the patients will remain on their assigned mode of ventilation throughout the duration of their mechanical weaning. The duration of each participants' mechanical weaning will differ on a case by case basis.

The PAV+ intervention differs from the standard PS treatment in that the software in the ventilator delivering PAV+ mode of ventilation measures resistance and elastance of the airway.Studies suggest this software may improve patient ventilator synchrony.
Intervention code [1] 285857 0
Treatment: Other
Comparator / control treatment
The Control treatment will be pressure support ventilation and this is what has been historically used as a ventilation weaning strategy in our Intensive Care Unit (ICU)
Control group
Active

Outcomes
Primary outcome [1] 288153 0
To evaluate if PAV+ leads to less ventilator time when compared to pressure support ventilation
Timepoint [1] 288153 0
This timepoint will be assessed from randomisation to completion of mechanical ventilation after the patient is extubated
Secondary outcome [1] 299519 0
1.ICU length of stay.
This will be assessed from the medical records
Timepoint [1] 299519 0
This timepoint is from randomisation until time of ICU discharge
Secondary outcome [2] 299533 0
2: Hospital length of stay
This will be assessed from the medical records
Timepoint [2] 299533 0
This timepoint is from randomisation until time of hospital discharge
Secondary outcome [3] 299534 0
ICU mortality
Medical records and patient charts
Timepoint [3] 299534 0
mortality during ICU stay
Secondary outcome [4] 299535 0
re intubation rate
Medical records will be reviewed
Timepoint [4] 299535 0
re intubation within 48 hours extubation
Once patients are removed from the ventilator and the endotracheal tube is removed it will be recorded through chart review as to how many patients required to be placed on the ventilator again,having failed extubation and liberation from the ventilator
Secondary outcome [5] 299536 0
hospital mortality
medical chart review
Timepoint [5] 299536 0
mortality whilst still in hospital

Eligibility
Key inclusion criteria
All patients ventilated on Puritan Bennett ventilator with PAV+ software who have been ventilated for at least 48 hours on a mode other than PAV+ or PS, and deemed ready for spontaneous ventilation
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are not likely to survive 24 hours
Patients admitted for palliation
Patients who are brain dead
Patients with hypoxic brain injury
Patients with a tracheostomy
Patients with neuromuscular injury or disease process
Unable to obtain consent/assent

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286135 0
Self funded/Unfunded
Name [1] 286135 0
Country [1] 286135 0
Primary sponsor type
Hospital
Name
Peninsula Health
Address
Frankston Hospital
Davey Street
Frankston
Victoria
Australia
3199
Country
Australia
Secondary sponsor category [1] 284950 0
None
Name [1] 284950 0
Address [1] 284950 0
Country [1] 284950 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288184 0
Peninsula Health Human Research Ethics Committee
Ethics committee address [1] 288184 0
Attention MS L Clavarino
Frankston Hospital
Box 52
Frankston
Victoria
3199
Ethics committee country [1] 288184 0
Australia
Date submitted for ethics approval [1] 288184 0
Approval date [1] 288184 0
18/07/2012
Ethics approval number [1] 288184 0
HREC/12/PH/56

Summary
Brief summary
The trial is a trial comparing two modes of mechanical weaning in patients in ICU who are eligible for weaning from mechanical ventilation
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34821 0
Address 34821 0
Country 34821 0
Phone 34821 0
Fax 34821 0
Email 34821 0
Contact person for public queries
Name 18068 0
Professor John Botha
Address 18068 0
PO Box 52, Hastings Rd Frankston
Victoria
3199
Country 18068 0
Australia
Phone 18068 0
+61 3 9784 7422
Fax 18068 0
+ 61 3 97696303
Email 18068 0
[email protected]
Contact person for scientific queries
Name 8996 0
Professor John Botha
Address 8996 0
PO Box 52, Hastings Rd Frankston
Victoria
3199
Country 8996 0
Australia
Phone 8996 0
+61 3 9784 7422
Fax 8996 0
+ 61 3 97696303
Email 8996 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.