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Trial registered on ANZCTR


Registration number
ACTRN12612000441819
Ethics application status
Approved
Date submitted
16/04/2012
Date registered
18/04/2012
Date last updated
10/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Variable Concentrations of Oxygen in Chronic Obstructive Pulmonary Disease
Scientific title
Response of Patients with Chronic Obstructive Pulmonary Disease to Variable Concentrations of Oxygen, as Measured by Carbon Dioxide
Secondary ID [1] 280278 0
Nil
Universal Trial Number (UTN)
U1111-1130-0109
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 286234 0
Condition category
Condition code
Respiratory 286449 286449 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oxygen administered to all participants at 28, 35 and 50%, each for 30 minutes with a 30 minute washout period following, via a venturi mask system.
Intervention code [1] 284629 0
Treatment: Other
Comparator / control treatment
Oxygen administered at 21% (room air concentration) for 30 minutes with a 30 minute washout period following, via a venturi mask system.
Control group
Dose comparison

Outcomes
Primary outcome [1] 286896 0
Transcutaneous carbon dioxide level, adjusted for baseline, as measured by a TOSCA monitor.
Timepoint [1] 286896 0
30 minutes.
Secondary outcome [1] 296930 0
Transcutaneous carbon dioxide level, adjusted for baseline, as measured by a TOSCA monitor.
Timepoint [1] 296930 0
Countinuously measured via the TOSCA, and specifically recorded at 10 minute intervals, during the intervention and washout periods.
Secondary outcome [2] 296932 0
Transcutaneous oxygen level, adjusted for baseline, as recorded on the TOSCA.
Timepoint [2] 296932 0
Continuously over the time course of the intervention and washout periods.
Secondary outcome [3] 296933 0
Effect of baseline transcutaneous carbon dioxide, as recoded via the TOSCA, on outcome.
Timepoint [3] 296933 0
Value from baseline.
Secondary outcome [4] 296934 0
Heart rate, adjusted for baseline, as recorded on the TOSCA.
Timepoint [4] 296934 0
10 minute intervals during the intervention and washout periods.
Secondary outcome [5] 296935 0
Respiratory rate, adjusted for baseline, counted by investigator.
Timepoint [5] 296935 0
10 minute intervals during the intervention and washout periods.

Eligibility
Key inclusion criteria
Diagnosis of chronic obstructive pulmonary disease with oxygen induced elevation in transcutaneous carbon dioxide levels of greater than or equal to 4mmHg.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
An intercurrent chest infection
FEV1:FVC >0.7
Baseline transcutaneous carbon dioxide of greater than 60mmHg
Diagnosis of a disease causing restriction to chest wall expansion (neuromuscular disease or chest wall dysfunction)
Obesity (body mass index greater than or equal to 40)
Any other condition which, at the investigator's discretion, is believed may present a safety risk or impact the feasibility of the study or the 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%, 28%, 35% or 50% oxygen). Allocation will be concealed using sealed opaque envelopes, which will only be opened once eligibilty has been confirmed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 4241 0
New Zealand
State/province [1] 4241 0

Funding & Sponsors
Funding source category [1] 285044 0
Charities/Societies/Foundations
Name [1] 285044 0
Medical Research Institute of New Zealand
Country [1] 285044 0
New Zealand
Funding source category [2] 285045 0
Government body
Name [2] 285045 0
Health Research Council
Country [2] 285045 0
New Zealand
Primary sponsor type
Individual
Name
Janine Pilcher
Address
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 283910 0
Individual
Name [1] 283910 0
Richard Beasley
Address [1] 283910 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [1] 283910 0
New Zealand
Other collaborator category [1] 260708 0
Individual
Name [1] 260708 0
Kyle Perrin
Address [1] 260708 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [1] 260708 0
New Zealand
Other collaborator category [2] 260709 0
Individual
Name [2] 260709 0
Pip Shirtcliffe
Address [2] 260709 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [2] 260709 0
New Zealand
Other collaborator category [3] 260710 0
Individual
Name [3] 260710 0
Mitesh Patel
Address [3] 260710 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [3] 260710 0
New Zealand
Other collaborator category [4] 260711 0
Individual
Name [4] 260711 0
Irene Braithwaite
Address [4] 260711 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [4] 260711 0
New Zealand
Other collaborator category [5] 260712 0
Individual
Name [5] 260712 0
Mathew Williams
Address [5] 260712 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [5] 260712 0
New Zealand
Other collaborator category [6] 260713 0
Individual
Name [6] 260713 0
Mark Weatherall
Address [6] 260713 0
Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [6] 260713 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287050 0
Health and Disability Ethics Committee: Northern Y
Ethics committee address [1] 287050 0
130 Grantham St, Hamilton 3204
Ethics committee country [1] 287050 0
New Zealand
Date submitted for ethics approval [1] 287050 0
12/01/2012
Approval date [1] 287050 0
28/03/2012
Ethics approval number [1] 287050 0
NTY/12/01/009

Summary
Brief summary
It is well established that oxygen therapy can increase carbon dioxide in patients with chronic obstructive pulmonary disease. However, the dose-response relationship is unknown, in particular whether this effect occurs above a certain oxygen concentration threshold.

This needs to be explored to ensure guidelines appropriately recommend oxygen prescription to minimise the incidence of hypercapnia (high carbon dioxide levels).

We plan to explore this with a randomised controlled four way cross over clinical trial of varying concentrations of oxygen therapy in chronic obstructive pulmonary disease patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34025 0
Address 34025 0
Country 34025 0
Phone 34025 0
Fax 34025 0
Email 34025 0
Contact person for public queries
Name 17272 0
Janine Pilcher
Address 17272 0
MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country 17272 0
New Zealand
Phone 17272 0
+64 4 8050241
Fax 17272 0
+64 4 3895707
Email 17272 0
[email protected]
Contact person for scientific queries
Name 8200 0
Janine Pilcher
Address 8200 0
MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country 8200 0
New Zealand
Phone 8200 0
+64 4 8050241
Fax 8200 0
+64 4 3895707
Email 8200 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.