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Trial registered on ANZCTR


Registration number
ACTRN12613000447752
Ethics application status
Approved
Date submitted
17/04/2013
Date registered
18/04/2013
Date last updated
16/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The Airvo Device and Oxygen Administration in Exacerbation of Chronic Obstructive Pulmonary Disease
Scientific title
Randomised Cross-Over Study to Investigate the Effects of Titrated Oxygen via Nasal Prongs and Airvo on Arterial Carbon Dioxide and Ventilation in Patients with an Exacerbation of Chronic Obstructive Pulmonary Disease
Secondary ID [1] 282285 0
None
Universal Trial Number (UTN)
U1111-1136-8920
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 288823 0
Condition category
Condition code
Respiratory 289180 289180 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oxygen administered via the Airvo device titrated to the patient's oxygen saturation at the start of the study (as measured via a TOSCA) for 30 minutes. Note this is to be followed by a 15 minute washout/observation period during which the patient is placed on the oxygen flow delivered at the start of the study.
Intervention code [1] 286914 0
Treatment: Devices
Comparator / control treatment
Oxygen administered via nasal prongs titrated to the patient's oxygen saturation at the start of the study (as measured via a TOSCA) for 30 minutes. Note this is to be followed by a 15 minute washout/observation period during which the patient is placed on the oxygen flow delivered at the start of the study.
Control group
Active

Outcomes
Primary outcome [1] 289291 0
Transcutaneous carbon dioxide (PtCO2), adjusted for baseline, measured via a TOSCA.
Timepoint [1] 289291 0
30 minutes.
Secondary outcome [1] 302178 0
Transcutaneous carbon dioxide, adjusted for baseline, measured via a TOSCA with continuous recording.
Timepoint [1] 302178 0
Continuous recording. Individual time points of every 5 minutes during intervention and washout/observation period
Secondary outcome [2] 302287 0
Respiratory rate, adjusted for baseline, measured via observation of patient and counting at 5 minute time points.
Timepoint [2] 302287 0
Every 5 minutes during intervention and washout/observation period.
Secondary outcome [3] 302289 0
Mean oxygen saturations, adjusted for baseline, measured via a TOSCA with continuous recording.
Timepoint [3] 302289 0
Continuous recording. Individual time points of every 5 minutes during intervention and washout/observation period.
Secondary outcome [4] 302290 0
Heart Rate, adjusted for baseline, measured via a TOSCA with continuous measuring.
Timepoint [4] 302290 0
Continuous recording. Individual time points of every 5 minutes during intervention and washout/observation period.
Secondary outcome [5] 302291 0
Comfort of the Airvo or nasal prongs by a questionnaire using 5 point scales and open ended questions.
Timepoint [5] 302291 0
Asked at end of trial session.

Eligibility
Key inclusion criteria
Twenty four participants with COPD will be recruited from Wellington Regional Hospital during an acute exacerbation. To be eligible participants will be receiving oxygen via standard nasal prongs, without any non invasive assisted ventilation at recruitment.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age under 16 years
2. 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)
Allocation concealment by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation: computer generated by a biostatistician
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety
Statistical methods / analysis
The primary analysis is a mixed linear model incorporating a fixed effect for order of administration and random participant effect. If there is no missing data, this is equivalent to a paired t test. Further exploratory analyses will include using baseline PtCO2 as covariate.
The sample size of 24 has 80% power, type I error rate 5%, to detect a difference of 2.4 mmHg. This is half the difference found in a study of participants with obesity hypoventilation syndrome which reported a mean (standard deviation) paired difference of 5 (4) mmHg.

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] 4999 0
New Zealand
State/province [1] 4999 0

Funding & Sponsors
Funding source category [1] 287065 0
Charities/Societies/Foundations
Name [1] 287065 0
Medical Research Institute of New Zealand
Address [1] 287065 0
Private Bag 7902
Newtown
Wellington
6242
Country [1] 287065 0
New Zealand
Funding source category [2] 287066 0
Commercial sector/Industry
Name [2] 287066 0
Fisher and Paykel
Address [2] 287066 0
Fisher & Paykel Healthcare Limited
15 Maurice Paykel Place
East Tamaki, Auckland 2013
PO Box 14 348
Panmure, Auckland 1741
Country [2] 287066 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
Private Bag 7902
Newtown
Wellington
6242
Country
New Zealand
Secondary sponsor category [1] 285841 0
None
Name [1] 285841 0
none
Address [1] 285841 0
Country [1] 285841 0
Other collaborator category [1] 277360 0
Individual
Name [1] 277360 0
Janine Pilcher
Address [1] 277360 0
Medical Research Institute of New Zealand
Private Bag 7902
Newtown
Wellington6242
Country [1] 277360 0
New Zealand
Other collaborator category [2] 277361 0
Individual
Name [2] 277361 0
Kyle Perrin
Address [2] 277361 0
Medical Research Institute of New Zealand
Private Bag 7902
Newtown
Wellington6242
Country [2] 277361 0
New Zealand
Other collaborator category [3] 277362 0
Individual
Name [3] 277362 0
Sharon Power
Address [3] 277362 0
Medical Research Institute of New Zealand
Private Bag 7902
Newtown
Wellington6242
Country [3] 277362 0
New Zealand
Other collaborator category [4] 277363 0
Individual
Name [4] 277363 0
Mark Weatherall
Address [4] 277363 0
CCDHB
Private Bag 7902
Newtown
Wellington6242
Country [4] 277363 0
New Zealand
Other collaborator category [5] 277364 0
Individual
Name [5] 277364 0
Richard Beasley
Address [5] 277364 0
Medical Research Institute of New Zealand
Private Bag 7902
Newtown
Wellington6242
Country [5] 277364 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289112 0
New Zealand Central Health and Disability Ethics Committee
Ethics committee address [1] 289112 0
1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 289112 0
New Zealand
Date submitted for ethics approval [1] 289112 0
Approval date [1] 289112 0
13/12/2012
Ethics approval number [1] 289112 0
12/CEN/80

Summary
Brief summary
The Airvo device has been developed to deliver oxygen to patients. It is not known, however, how this method of delivery influences blood carbon dioxide levels. In some patients there is a chance of oxygen causing hypercapnia (elevation in blood carbon dioxide), this includes those with chronic obstructive pulmonary disease (COPD).

To understand clinical utility and safety, it is crucial to determine how supplementary oxygen administered by the Airvo device influences carbon dioxide and compare this with similar oxygen concentrations delivered by nasal cannulae.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39146 0
Prof Richard Beasley
Address 39146 0
Medical Research Institute of New Zealand
Private Bag 7902
Newtown
Wellington
6242
Country 39146 0
New Zealand
Phone 39146 0
+6448050147
Fax 39146 0
Email 39146 0
richard.beasley@mrinz.ac.nz
Contact person for public queries
Name 39147 0
Dr Janine Pilcher
Address 39147 0
Medical Research Institute of New Zealand
Private Bag 7902
Newtown
Wellington
6242
Country 39147 0
New Zealand
Phone 39147 0
+6448050147
Fax 39147 0
Email 39147 0
janine.pilcher@mrinz.ac.nz
Contact person for scientific queries
Name 39148 0
Dr Janine Pilcher
Address 39148 0
Medical Research Institute of New Zealand
Private Bag 7902
Newtown
Wellington
6242
Country 39148 0
New Zealand
Phone 39148 0
+6448050147
Fax 39148 0
Email 39148 0
janine.pilcher@mrinz.ac.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