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Trial registered on ANZCTR


Registration number
ACTRN12605000474651
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
23/09/2005
Date last updated
16/01/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of breathing circuit size on paediatric ventilatory parameters
Scientific title
Effect of Adult and infant breathing circuits on intubated paediatric ventilator patients with respect to delivered tidal volume.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric patient receiving ventilatory support 595 0
Condition category
Condition code
Respiratory 668 668 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study (Adult or infant breathing circuit, depending on weight) for 12 hours. Participants will then be crossed over to the opposing circuit.
Intervention code [1] 461 0
None
Comparator / control treatment
Control (standard paediatric breathing circuit).
Control group
Active

Outcomes
Primary outcome [1] 793 0
Delivered Tidal Volume
Timepoint [1] 793 0
Measured every 30 minutes
Secondary outcome [1] 1611 0
Arterial Blood Gas
Timepoint [1] 1611 0
Taken every 3 hours.
Secondary outcome [2] 1612 0
Oxygenation index
Timepoint [2] 1612 0
Taken every 3 hours.

Eligibility
Key inclusion criteria
Patients weighing between 10-35kg.Patients that are intubated.Patients that have been ventilated for over 24hrs.Patients that have any kind of physical lung injury, that could significantly alter lung characteristics i.e. Pneumothorax.Patients that have not been able to be stabile in order for cross over to occur.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Generated by independent party, randomised to blocks
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 200 0
New Zealand
State/province [1] 200 0

Funding & Sponsors
Funding source category [1] 736 0
Commercial sector/Industry
Name [1] 736 0
Fisher & Paykel Healthcare
Address [1] 736 0
15 Maurice Paykel Place. East Tamaki. Auckland
Country [1] 736 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare
Address
15 Maurice Paykel Place. East Tamaki. Auckland 2013
Country
New Zealand
Secondary sponsor category [1] 610 0
None
Name [1] 610 0
N/A
Address [1] 610 0
Country [1] 610 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1931 0
Mater Misericordiae Health services Brisbane
Ethics committee address [1] 1931 0
Ethics committee country [1] 1931 0
Australia
Date submitted for ethics approval [1] 1931 0
Approval date [1] 1931 0
Ethics approval number [1] 1931 0

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

Contacts
Principal investigator
Name 36304 0
Address 36304 0
Country 36304 0
Phone 36304 0
Fax 36304 0
Email 36304 0
Contact person for public queries
Name 9650 0
Dr. Andreas Schibler
Address 9650 0
Mater Children's Hospital Mater
Mater Misericordiae Hospitals
South Brisbane QLD 4101
Country 9650 0
Australia
Phone 9650 0
+61 7 38408111
Fax 9650 0
+61 7 38401642
Email 9650 0
andreas_schibler@mater.org.au
Contact person for scientific queries
Name 578 0
Geraldine Keogh
Address 578 0
Fisher & Paykel Healthcare
PO Box 14 348
Panmure
Country 578 0
New Zealand
Phone 578 0
+ 64 9 574 0100
Fax 578 0
+ 64 9 574 0158
Email 578 0
geraldine.keogh@fphcare.co.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary