Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000356864
Ethics application status
Approved
Date submitted
28/03/2012
Date registered
28/03/2012
Date last updated
16/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
High Concentration Oxygen in Bronchiectasis
Scientific title
Response of Patients with Bronchiectasis to Hyperoxia and Normoxia, as Measured by Carbon Dioxide Levels
Secondary ID [1] 280229 0
Nil
Universal Trial Number (UTN)
U1111-1129-5351
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis 286176 0
Condition category
Condition code
Respiratory 286371 286371 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
50% oxygen administration for 30 minutes via a full-face continuous positive airway pressure mask without positive airway pressure. Followed by a 30 minute washout period.
Intervention code [1] 284562 0
Treatment: Other
Comparator / control treatment
21% oxygen administration for 30 minutes via a full-face continuous positive airway pressure mask without positive airway pressure. Followed by a 30 minute washout period.
Control group
Placebo

Outcomes
Primary outcome [1] 286826 0
Transcutaneous carbon dioxide level, as measured by a TOSCA monitor.
Timepoint [1] 286826 0
30 minutes.
Secondary outcome [1] 296747 0
Transcutaneous carbon dioxide level as measured by a TOSCA monitor.
Timepoint [1] 296747 0
10 and 20 minutes.
Secondary outcome [2] 296748 0
Minute Ventilation, calculated using data from a flow sensor attached to the expiratory port of the participant's mask.
Timepoint [2] 296748 0
10, 20 and 30 minutes.
Secondary outcome [3] 296749 0
Volume of dead space to tidal volume, calculated using data from a flow sensor attached to the expiratory port of the participant's mask and volumetric capnography.
Timepoint [3] 296749 0
10, 20 and 30 minutes.
Secondary outcome [4] 296750 0
Change in transcutaneous carbon dioxide greater than or equal to 4mmHg, as measured by a TOSCA monitor.
Timepoint [4] 296750 0
30 minutes.
Secondary outcome [5] 296751 0
Change in transcutaneous carbon dioxide greater than or equal to 10mmHg, as measured by a TOSCA monitor.
Timepoint [5] 296751 0
30 minutes.
Secondary outcome [6] 296752 0
Tidal volume, calculated using data from a flow sensor attached to the expiratory port of the participant's mask and volumetric capnography.
Timepoint [6] 296752 0
10, 20 and 30 minutes.
Secondary outcome [7] 296753 0
Volume of dead space, calculated using data from a flow sensor attached to the expiratory port of the participant's mask and volumetric capnography.
Timepoint [7] 296753 0
10, 20 and 30 minutes.
Secondary outcome [8] 296754 0
Alveolar volume, calculated using data from a flow sensor attached to the expiratory port of the participant's mask and volumetric capnography.
Timepoint [8] 296754 0
10, 20 and 30 minutes.
Secondary outcome [9] 296755 0
Alveolar minute ventilation, calculated using data from a flow sensor attached to the expiratory port of the participant's mask and volumetric capnography.
Timepoint [9] 296755 0
10, 20 and 30 minutes.
Secondary outcome [10] 296756 0
Oxygen saturations, as recorded on the TOSCA via continuous electronic recording data download.
Timepoint [10] 296756 0
Continuously over the timecourse of the intervention and washout period.
Secondary outcome [11] 296757 0
Effect of baseline transcutaneous carbon dioxide, spirometry and CT findings on all outcomes.
Timepoint [11] 296757 0
Values at Baseline.
Secondary outcome [12] 296840 0
Heart Rate, measured from the TOSCA
Timepoint [12] 296840 0
10, 20 and 30 minutes
Secondary outcome [13] 296841 0
Respiratory Rate, measured from capnography equipment
Timepoint [13] 296841 0
10, 20 and 30 minutes

Eligibility
Key inclusion criteria
Bronchiectasis diagnosed by a doctor and confirmed on CT scanning.
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of infection with Burkholderia
Baseline transcutaneous carbon dioxide level of greater than or equal to 60 mmHg
Diagnosis of chronic obstructive pulmonary disease
Over 10 pack year smoking history
Obesity (body mass index equal to or greater than 40)
Any other condition which, at the investigator's discretion, is believed may present a safety risk of impact feasiblity of the study of study results

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)
Following explaination of the trial and consent, participants will be assessed for eligibility. If eligible, participants will be randomised to the order of interventions (21% oxygen and 50% oxygen). This order will be available to an investigator who is not administering treatment, assessing outcomes or analysing data. Their role is to make available the gas bottles and bags (containing either 21% or 50% oxygen) in the randomised order. The labels on the bottles will be covered to maintain the blinding of other investigators and the participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
By computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
All outcome measures will be adjusted for baseline in the data analysis.
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/04/2012
Actual
12/06/2012
Date of last participant enrolment
Anticipated
Actual
4/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 4225 0
New Zealand
State/province [1] 4225 0

Funding & Sponsors
Funding source category [1] 284985 0
Government body
Name [1] 284985 0
Health Research Council of New Zealand
Country [1] 284985 0
New Zealand
Funding source category [2] 284987 0
Charities/Societies/Foundations
Name [2] 284987 0
Medical Research Institute of New Zealand
Country [2] 284987 0
New Zealand
Primary sponsor type
Individual
Name
Janine Pilcher
Address
MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 283849 0
Individual
Name [1] 283849 0
Richard Beasley
Address [1] 283849 0
MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [1] 283849 0
New Zealand
Other collaborator category [1] 260660 0
Individual
Name [1] 260660 0
Kyle Perrin
Address [1] 260660 0
MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [1] 260660 0
New Zealand
Other collaborator category [2] 260661 0
Individual
Name [2] 260661 0
Pip Shirtcliffe
Address [2] 260661 0
MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [2] 260661 0
New Zealand
Other collaborator category [3] 260662 0
Individual
Name [3] 260662 0
Mitesh Patel
Address [3] 260662 0
MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [3] 260662 0
New Zealand
Other collaborator category [4] 260663 0
Individual
Name [4] 260663 0
Mathew Williams
Address [4] 260663 0
MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [4] 260663 0
New Zealand
Other collaborator category [5] 260664 0
Individual
Name [5] 260664 0
Mark Weatherall
Address [5] 260664 0
Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [5] 260664 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286994 0
Health and Disability Ethics Committee: Central
Ethics committee address [1] 286994 0
Ethics committee country [1] 286994 0
New Zealand
Date submitted for ethics approval [1] 286994 0
18/11/2011
Approval date [1] 286994 0
23/03/2012
Ethics approval number [1] 286994 0
CEN/11/12/075

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

Contacts
Principal investigator
Name 33987 0
Dr Janine Pilcher
Address 33987 0
MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country 33987 0
New Zealand
Phone 33987 0
+64 4 8050241
Fax 33987 0
Email 33987 0
janine.pilcher@mrinz.ac.nz
Contact person for public queries
Name 17234 0
Janine Pilcher
Address 17234 0
MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country 17234 0
New Zealand
Phone 17234 0
+64 4 8050241
Fax 17234 0
+64 4 3895707
Email 17234 0
janine.pilcher@mrinz.ac.nz
Contact person for scientific queries
Name 8162 0
Janine Pilcher
Address 8162 0
MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country 8162 0
New Zealand
Phone 8162 0
+64 4 8050241
Fax 8162 0
+64 4 3895707
Email 8162 0
janine.pilcher@mrinz.ac.nz

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
ThesisNo https://researcharchive.vuw.ac.nz/xmlui/handle/100... [More Details]

Documents added automatically
No additional documents have been identified.