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Trial registered on ANZCTR


Registration number
ACTRN12615001056583
Ethics application status
Approved
Date submitted
22/09/2015
Date registered
7/10/2015
Date last updated
5/04/2019
Date data sharing statement initially provided
5/04/2019
Date results information initially provided
5/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
High concentration oxygen in Chronic Obstructive Pulmonary Disease (COPD): Study 2
Scientific title
Response of Patients with COPD to Hyperoxia and Normoxia, as Measured by Carbon Dioxide Levels: Study 2
Secondary ID [1] 287501 0
Nil
Universal Trial Number (UTN)
U1111-1150-9928
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 296255 0
Condition category
Condition code
Respiratory 296524 296524 0 0
Chronic obstructive pulmonary disease

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] 292885 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] 296152 0
Transcutaneous carbon dioxide level, as measured by a Sentec monitor.
Timepoint [1] 296152 0
30 minutes.
Secondary outcome [1] 317622 0
Transcutaneous carbon dioxide level, as measured by a Sentec monitor.
Timepoint [1] 317622 0
10 and 20 minutes.
Secondary outcome [2] 317623 0
Respiratory rate, measured from capnography equipment.
Timepoint [2] 317623 0
10, 20 and 30 minutes.
Secondary outcome [3] 317624 0
Minute ventilation, calculated using data from a flow sensor attached to the expiratory port of the participant's mask.
Timepoint [3] 317624 0
10, 20 and 30 minutes.
Secondary outcome [4] 317625 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 [4] 317625 0
10, 20 and 30 minutes.
Secondary outcome [5] 317626 0
Change in transcutaneous carbon dioxide greater than or equal to 4mmHg, as measured by the Sentec monitor.
Timepoint [5] 317626 0
30 minutes.
Secondary outcome [6] 317627 0
Change in transcutaneous carbon dioxide greater than or equal to 10mmHg, as measured by the Sentec monitor.
Timepoint [6] 317627 0
30 minutes.
Secondary outcome [7] 317628 0
Effect of baseline transcutaneous carbon dioxide (measured via Sentec) and FEV1 (measured via spirometry) on outcomes.
Timepoint [7] 317628 0
Baseline.
Secondary outcome [8] 317629 0
Tidal volume, calculated using data from a flow sensor attached to the expiratory port of the participant's mask and volumetric capnography.
Timepoint [8] 317629 0
10, 20 and 30 minutes.
Secondary outcome [9] 317631 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 [9] 317631 0
10, 20 and 30 minutes.
Secondary outcome [10] 317632 0
Alveolar volume, calculated using data from a flow sensor attached to the expiratory port of the participant's mask and volumetric capnography.
Timepoint [10] 317632 0
10, 20 and 30 minutes.
Secondary outcome [11] 317634 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 [11] 317634 0
10, 20 and 30 minutes.
Secondary outcome [12] 317635 0
Oxygen saturations, as recorded on the Sentec via continuous electronic recording data download.
Timepoint [12] 317635 0
Continuously over the timecourse of the intervention and washout period.
Secondary outcome [13] 317636 0
Heart rate, measured from the Sentec.
Timepoint [13] 317636 0
10, 20 and 30 minutes.
Secondary outcome [14] 317643 0
End tidal carbon dioxide, calculated using the capnography sensor attached to expiratory port of participant's mask.
Timepoint [14] 317643 0
10, 20 and 30 minutes.
Secondary outcome [15] 317644 0
Transcutaneous carbon dioxide level as measured by Sentec and with drift correction by Sentec computer software
Timepoint [15] 317644 0
At 30 minutes and during capillary blood gas measurement (end of second study washout).
Secondary outcome [16] 317645 0
Evaluation of outcomes above in comparison to results from a study of similar design in patients with bronchiectasis (ACTRN12615000971538).
Timepoint [16] 317645 0
Time points as above.
Secondary outcome [17] 317646 0
Capillary blood gas value, measured after completion of second washout while Sentec monitor is in place.
Timepoint [17] 317646 0
After completion of second washout.
Secondary outcome [18] 317647 0
Transcutaneous carbon dioxide level, measured by Sentec during capillary blood gas measurement.
Timepoint [18] 317647 0
During capillary blood gas sample (i.e. after completion of second washout).

Eligibility
Key inclusion criteria
COPD, as diagnosed by a doctor.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Baseline transcutaneous carbon dioxide of greater than or equal to 60mmHg
2. FEV1:FVC ratio >0.7
3. Age under 16 years
4. A diagnosis of bronchiectasis
5. Morbid obesity (with a body mass index of greater than or equal to 40)
6. Inability to match FEV1 percentage predicted to a participant that took part in the bronchiectasis oxygen study*
7. 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.

*This study is designed to allow for comparison of results to a study of similar design in patients with bronchiectasis (ACTRN12615000971538). Participants will therefore be matched by FEV1 to the participants in the bronchiectasis study (the COPD participant must have an FEV1 percentage predicted within an absolute value of 5% of the FEV1 percentage predicted for the bronchiectasis patient (values inclusive)). An exception to this is for the three bronchiectasis participants that had FEV1 percentage predicted values of 109% or higher, who are to be matched with COPD participants with an FEV1 percent predicted of 80% or over (i.e. participants in the mildest COPD severity category based on FEV1).

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 explanation 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). Allocation will be concealed using sealed opaque envelopes, opened at the time of randomisation. The unblinded investigator will 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 blinded investigator (who will record outcome data) 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
Outcomes will be adjusted for baseline in the data analysis.
Phase
Type of endpoint(s)
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] 7175 0
New Zealand
State/province [1] 7175 0

Funding & Sponsors
Funding source category [1] 292076 0
Government body
Name [1] 292076 0
Health Research Council of New Zealand
Address [1] 292076 0
Level 3 - ProCARE Building, Grafton Mews, at 110 Stanley Street, Auckland 1010
Country [1] 292076 0
New Zealand
Funding source category [2] 292077 0
Charities/Societies/Foundations
Name [2] 292077 0
Medical Research Institute of New Zealand
Address [2] 292077 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [2] 292077 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 290754 0
None
Name [1] 290754 0
Address [1] 290754 0
Country [1] 290754 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293560 0
Health and Disability Ethics Committee
Ethics committee address [1] 293560 0
20 Aitken Street
Wellington 6011
Ethics committee country [1] 293560 0
New Zealand
Date submitted for ethics approval [1] 293560 0
Approval date [1] 293560 0
24/12/2013
Ethics approval number [1] 293560 0
13/STH/200

Summary
Brief summary
This study directly relates to the trial
ACTRN12614000361606. As there is concern regarding the accuracy of the data collected by the specific transcutaneous probes used with that study (measuring carbon dioxide, oxygen levels and heart rate), the study is being repeated using a Sentec transcutaneous monitor. The Ethics approval number and UTN remain the same, however ANZCTR required a new trial registration number. Two new outcome measures have been added (end tidal carbon dioxide, to further assess the mechanisms behind any change in carbon dioxide, and drift corrected carbon dioxide (a function of the Sentec monitor to improve accuracy)). In addition, an arteriolised blood gas will be performed at the end of the study to validate the Sentec.

Oxygen therapy has been shown to increase carbon dioxide in the blood of patients with certain respiratory conditions. This study aims to find out if oxygen therapy increases carbon dioxide levels in patients with COPD, and compare data to that from patients with bronchiectasis or cystic fibrosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60454 0
Dr Janine Pilcher
Address 60454 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington, 6021
Country 60454 0
New Zealand
Phone 60454 0
+64 4 8050147
Fax 60454 0
Email 60454 0
janine.pilcher@mrinz.ac.nz
Contact person for public queries
Name 60455 0
Dr Janine Pilcher
Address 60455 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington, 6021
Country 60455 0
New Zealand
Phone 60455 0
+64 4 8050147
Fax 60455 0
Email 60455 0
janine.pilcher@mrinz.ac.nz
Contact person for scientific queries
Name 60456 0
Dr Janine Pilcher
Address 60456 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington, 6021
Country 60456 0
New Zealand
Phone 60456 0
+64 4 8050147
Fax 60456 0
Email 60456 0
janine.pilcher@mrinz.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data available on request.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary