Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000471583
Ethics application status
Approved
Date submitted
2/03/2015
Date registered
14/05/2015
Date last updated
13/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of the AIRVO on arterial carbon dioxide (PaCO2) in patients with stable Chronic Obstructive Pulmonary Disease (COPD).
Scientific title
A randomised crossover trial investigating the effect of the Fisher & Paykel Healthcare AIRVO high flow nasal therapy on PaCO2 in patients with stable COPD.
Secondary ID [1] 286240 0
nil
Universal Trial Number (UTN)
U111111645712
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 294291 0
Condition category
Condition code
Respiratory 294612 294612 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be three AIRVO interventions each lasting 20 minutes. These will involve breathing heated and humidified room air through the AIRVO nasal interface (nasal prongs which sit inside both nostrils). Three different flow rates will be used: 45L/min, 30L/min and 15L/min.
A 15 minute 'washout' period will follow each intervention. During this time the subject will breathe room air without any breathing apparatus.
Note: The 45 L/min intervention will have 30 seconds of delivery at 30L/min at the beginning to allow the participant to more comfortably get used to the subsequent 45 L/min level.
Intervention code [1] 291255 0
Treatment: Devices
Comparator / control treatment
Breathing room air through without the AIRVO for 20 minutes.
Control group
Active

Outcomes
Primary outcome [1] 294377 0
Change in transcutaneous carbon dioxide (PtCO2) from baseline,* as measured by a small heated transcutaneous probe which attaches painlessly to the earlobe.

*baseline is the measurement taken at t=0 at the start of each intervention
Timepoint [1] 294377 0
20 minutes
Secondary outcome [1] 313139 0
PtCO2 change from baseline* at 5 minute intervals throughout the interventions and at the end of the subsequent 15 minute washout period, as measured by a small heated transcutaneous probe which attaches painlessly to the earlobe.

*baseline is the measurement taken at t=0 at the start of each intervention
Timepoint [1] 313139 0
5 minute intervals (t=5, t=10, t=15) and at the end of the subsequent 15 minute washout period.
Secondary outcome [2] 313261 0
The proportion of patients that have a decrease in PtCO2 by greater than or equal to 4mmHg, as measured by a small heated transcutaneous probe which attaches painlessly to the earlobe.
Timepoint [2] 313261 0
20 mins
Secondary outcome [3] 313262 0
Oxygen saturation change from baseline*, at 5 minute intervals during the intervention and at the end of the subsequent 15 minute washout, as measured by a small heated transcutaneous probe which attaches painlessly to the earlobe.

*baseline is the measurement taken at t=0 at the start of each intervention
Timepoint [3] 313262 0
At 5 minute intervals during the intervention and at the end of the subsequent 15 minute washout.
Secondary outcome [4] 313263 0
Heart rate change from baseline*, at 5 minute intervals during the intervention and at the end of the subsequent 15 minute washout, as measured by a small heated transcutaneous probe which attaches painlessly to the earlobe.

*baseline is the measurement taken at t=0 at the start of each intervention
Timepoint [4] 313263 0
At 5 minute intervals during the intervention and at the end of the subsequent 15 minute washout.
Secondary outcome [5] 313264 0
Respiratory rate change from baseline*, at 5 minute intervals during the intervention and at the end of the subsequent 15 minute washout, as counted by an investigator over 1 minute and measured by elasticated plethysmography bands which sit comfortably around the participant's chest/upper abdomen throughout the visit.

*baseline is the measurement taken at t=0 at the start of each intervention
Timepoint [5] 313264 0
At 5 minute intervals during the intervention and at the end of the subsequent 15 minute washout.
Secondary outcome [6] 313265 0
Minute ventilation change from baseline*, at 5 minute intervals during the intervention and at the end of the subsequent 15 minute washout, as measured by elasticated plethysmography bands which sit comfortably around the participant's chest/upper abdomen throughout the visit. Predicted and actual values of calibration testing before and after an intervention will be used to assess stability and accuracy. If instability (accuracy less than 90%) is found at the end of an intervention the data for that intervention will be discarded.

*baseline measurements are taken at t=0 of the same intervention
Timepoint [6] 313265 0
At 5 minute intervals during the intervention and at the end of the subsequent 15 minute washout.
Secondary outcome [7] 313266 0
Proportion of participants who withdrew from the intervention before it was completed
Timepoint [7] 313266 0
20 mins
Secondary outcome [8] 313267 0
Tolerability questionnaire results: questionnaires have been designed specifically for this study.
Timepoint [8] 313267 0
Questionnaires will be administered following each AIRVO intervention during the 15 minute washout period.

Eligibility
Key inclusion criteria
1. A doctor’s diagnosis of COPD
2. Age greater than or equal to 40 years
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Smoking pack year history <10 years
2. FEV1/FVC >70%
3. Long term oxygen therapy
4. COPD not deemed to be ‘stable’:
a. Current exacerbation requiring acute treatment with short course antibiotic/oral steroid or oxygen therapy.
b. Hospital admission for an acute exacerbation of COPD in the last 6 weeks.
5. Nasal conditions such as deviated septum, chronic rhinitis, current cold/flu which, in the evaluation by the investigator, could impair nasal breathing.
6. Any other condition, which at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or 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)
Participants will be considered enrolled and part of the study population at the time the Consent Form has been filled in by both the Participant and Study Investigator.

The Blinded Investigator responsible for documenting PtCO2, heart rate and oxygen saturations, will be blinded to which AIRVO intervention the participant is receiving by a screen and wearing earplugs. A second Un-blinded Investigator will be responsible for opening an opaque envelope containing the randomised treatment, applying and calibrating the plethysmography bands for measuring minute ventilation, administering the randomised treatment, and recording respiratory rate. The participant will not be told the order they receive the different flow rates via the AIRVO 2. We will ask them not to divulge any detected differences in flow to the investigators due to risk of un-blinding the Blinded Investigator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation code will be pre-generated by the study statistician by computer and stored in a sealed opaque envelope which will be opened by the Un-Blinded Investigator at randomisation (immediately prior to the first intervention).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Randomised controlled 4 way crossover trial.
Two investigators will carry out each study visit: one of these will be blinded to the treatment allocation and one unblinded. Participants will not be told in which order they will receive the interventions.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/05/2015
Actual
20/05/2015
Date of last participant enrolment
Anticipated
1/03/2016
Actual
23/02/2016
Date of last data collection
Anticipated
Actual
23/02/2016
Sample size
Target
48
Accrual to date
Final
48
Recruitment outside Australia
Country [1] 6706 0
New Zealand
State/province [1] 6706 0
Wellington

Funding & Sponsors
Funding source category [1] 290838 0
Commercial sector/Industry
Name [1] 290838 0
Fisher and Paykel Healthcare
Country [1] 290838 0
New Zealand
Funding source category [2] 290839 0
Charities/Societies/Foundations
Name [2] 290839 0
Medical Research Institute of New Zealand
Country [2] 290839 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
Medical Research Institute of New Zealand
Level 7 CSB
Wellington Regional Hospital
Riddiford Street
Newtown
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 289530 0
None
Name [1] 289530 0
Address [1] 289530 0
Country [1] 289530 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292462 0
Health and Disability Ethics Committee New Zealand
Ethics committee address [1] 292462 0
Ministry of Health
Ethics Department
Reception - Ground Floor
20 Aitken Street
Thorndon
WELLINGTON 6011
Ethics committee country [1] 292462 0
New Zealand
Date submitted for ethics approval [1] 292462 0
23/01/2015
Approval date [1] 292462 0
25/02/2015
Ethics approval number [1] 292462 0
15/NTA/4

Summary
Brief summary
This study will investigate the effect of the AIRVO device (high flow nasal therapy) on the blood levels of carbon dioxide (PaCO2) in participants with stable chronic obstructive pulmonary disease (COPD).
Acute exacerbations of this condition cause a build-up of carbon dioxide in the blood which can require ventilation and increase risk of death. Acute exacerbations of COPD lead to 9000 hospital admissions in New Zealand every year. High flow nasal therapy has a potential role in lowering carbon dioxide levels in COPD patients and we therefore wish to study the effects further.
Participants will undergo an informed consent process, gathering of personal/medical information and lung function testing. They will then be randomised to the order they receive 4 interventions for 20 minutes at a time and a ‘washout’ period of 15 minutes after each. The AIRVO device will be used to deliver air for 3 interventions at different flow rates. The 4th intervention will be 20mins of the participant breathing room air whilst being monitored. The participant will be asked to complete a tolerability questionnaire following each 20 minute intervention with the AIRVO.
The primary aim of the study is to identify whether the AIRVO device has an impact on PaCO2 levels in participants. Secondary outcomes include how well participants tolerate the AIRVO machine and other physical parameters such as respiratory rate, oxygen saturations, minute ventilation and heart rate.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54990 0
Prof Richard Beasley
Address 54990 0
Medical Research Institute of New Zealand
Level 7 CSB Wellington Regional Hospital
Riddiford Street
Newtown
Wellington 6021
Country 54990 0
New Zealand
Phone 54990 0
+64-4-805 0147
Fax 54990 0
Email 54990 0
[email protected]
Contact person for public queries
Name 54991 0
Dr Janine Pilcher
Address 54991 0
Medical Research Institute of New Zealand
Private Bag 7902
Newtown
Wellington
6242
Country 54991 0
New Zealand
Phone 54991 0
+64 4 805 0241
Fax 54991 0
Email 54991 0
[email protected]
Contact person for scientific queries
Name 54992 0
Dr Janine Pilcher
Address 54992 0
Medical Research Institute of New Zealand
Private Bag 7902
Newtown
Wellington
6242
Country 54992 0
New Zealand
Phone 54992 0
+64 4 805 0241
Fax 54992 0
Email 54992 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
SourceTitleYear of PublicationDOI
EmbaseNasal high flow therapy and PtCO2 in stable COPD: A randomized controlled cross-over trial.2018https://dx.doi.org/10.1111/resp.13185
N.B. These documents automatically identified may not have been verified by the study sponsor.