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Trial registered on ANZCTR


Trial ID
ACTRN12612000410853
Ethics application status
Approved
Date submitted
10/04/2012
Date registered
12/04/2012
Date last updated
10/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The Airvo Device and Oxygen Administration in Chronic Obstructive Pulmonary Disease
Scientific title
Response of Patients with Chronic Obstructive Pulmonary Disease to Airvo, as Measured by Carbon Dioxide Levels
Secondary ID [1] 280265 0
Nil
Universal Trial Number (UTN)
U1111-1129-6652
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 286213 0
Condition category
Condition code
Respiratory 286427 286427 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oxygen administered via the Airvo device at the setting of 25 Litres per minute, titrated to achieve a target participant oxygen saturation of 96%, over a period of 30 minutes. This will be followed by a 15 minute washout period.

Oxygen administered via the Airvo device at the setting of 45 Litres per minute, titrated to achieve a target participant oxygen saturation of 96%, over a period of 30 minutes. This will be followed by a 15 minute washout period.

Note prior to the above, tolerability to the Airvo will be tested at 25 Litres per minute for 15 minutes, followed by 45 Litres per minute. This will be done on room air.

Note oxygen saturations will be measured via a TOSCA.
Intervention code [1] 284614 0
Treatment: Other
Comparator / control treatment
Oxygen administered via nasal prongs with the oxygen flow starting at 1.5L per minute and then titrated to achieve a target participant oxygen saturation of 96%, over a period of 30 minutes. This will be followed by a 15 minute washout period.

Note oxygen saturations will be measured via a TOSCA.
Control group
Active

Outcomes
Primary outcome [1] 286869 0
Transcutaneous carbon dioxide, adjusted for baseline, measured via a TOSCA.
Timepoint [1] 286869 0
30 minutes.
Secondary outcome [1] 296861 0
Transcutaneous carbon dioxide, adjusted for baseline, measured via a TOSCA with continuous recording. Analysis of individual data points and timecourse of any change in carbon dioxide.
Timepoint [1] 296861 0
Continuous recording. Individual time points of 10 and 20 minutes.
Secondary outcome [2] 296862 0
Respiratory rate, adjusted for baseline, measured via plethysmography with continuous recording.
Timepoint [2] 296862 0
Continuous recording. Individual time points of 10, 20 and 30 minutes.
Secondary outcome [3] 296863 0
Tidal volume, adjusted for baseline, measured via plethysmography with continuous recording.
Timepoint [3] 296863 0
Continuous recording. Individual time points of 10, 20 and 30 minutes.
Secondary outcome [4] 296864 0
Mean oxygen saturations, adjusted for baseline, measured via a TOSCA with continuous recording.
Timepoint [4] 296864 0
Continuous recording during interventions.
Secondary outcome [5] 296865 0
Comparison of the above outcome measures to values from the 15 minute tolerability periods on Airvo at 25 and 45 Litres per minute without added oxygen.
Timepoint [5] 296865 0
Continuous recording and individual time point of 10 minutes.
Secondary outcome [6] 296866 0
Tolerability of the Airvo- by verbally asking the participant if they will be willing to wear it at 25 Litres for 30 minutes continuously and at 45 Litres for 30 minutes continuously.
Timepoint [6] 296866 0
Following the 15 minute tolerability periods on Airvo at 25 and 45 Litres per minute without oxygen.
Secondary outcome [7] 296867 0
Comfort of the Airvo or nasal prongs by a questionnaire with ratings from 1 through to 5 of comfort for various aspects of use.
Timepoint [7] 296867 0
Filled in following each of the 30 minute interventions.
Secondary outcome [8] 296929 0
Volume of dead space and dead space to tidal volume ratio, calculated from data from plethysmography.
Timepoint [8] 296929 0
Collected data from baseline.
Secondary outcome [9] 296976 0
Heart Rate, adjusted for baseline, measured via a TOSCA with continuous measuring.
Timepoint [9] 296976 0
Continuous measuring during interventions.
Secondary outcome [10] 297024 0
Minute Ventilation, adjusted for baseline, measured via plethysmography with continuous recording.
Timepoint [10] 297024 0
Continuous recording. Individual time points of 10, 20 and 30 minutes.

Eligibility
Key inclusion criteria
Diagnosis of chronic obstructive pulmonary disease with baseline oxygen saturations of 85-92%. A raise in transcutaneous carbon dioxide of greater than or equal to 4mmHg on eligibility testing (50% oxygen administration via a mask until transcutaneous carbon dioxide increases by greater than or equal to 4mmHg or for 20 minutes).
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
An intercurrent chest infection
FEV1>50% predicted
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)
Inability to tolerate the Airvo device at 25 and 45 Litres per minute
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 eilgible, participants will be randomised to the order of interventions (Airvo at 25 Litres per minute, Airvo at 45 Litres per minute and nasal prongs). The individual analysing the data will have the treatment order allocation concealled from them by giving each of the treatments a code (e.g. A, B or C) on the data spreadsheet.
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
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] 4235 0
New Zealand
State/province [1] 4235 0

Funding & Sponsors
Funding source category [1] 285023 0
Charities/Societies/Foundations
Name [1] 285023 0
Medical Research Institute of New Zealand
Address [1] 285023 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [1] 285023 0
New Zealand
Funding source category [2] 285024 0
Commercial sector/Industry
Name [2] 285024 0
Fisher and Paykel
Address [2] 285024 0
15 Maurice Paykel Place, East Tamaki, Auckland 2013
Country [2] 285024 0
New Zealand
Funding source category [3] 285025 0
Government body
Name [3] 285025 0
Health Research Council
Address [3] 285025 0
Level 3 - ProCARE Building, Grafton Mews, at 110 Stanley Street, Auckland 1010
Country [3] 285025 0
New Zealand
Primary sponsor type
Individual
Name
Richard Beasley
Address
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 283888 0
Individual
Name [1] 283888 0
Janine Pilcher
Address [1] 283888 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [1] 283888 0
New Zealand
Other collaborator category [1] 260689 0
Individual
Name [1] 260689 0
Kyle Perrin
Address [1] 260689 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [1] 260689 0
New Zealand
Other collaborator category [2] 260690 0
Individual
Name [2] 260690 0
Pip Shirtcliffe
Address [2] 260690 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [2] 260690 0
New Zealand
Other collaborator category [3] 260691 0
Individual
Name [3] 260691 0
Mitesh Patel
Address [3] 260691 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [3] 260691 0
New Zealand
Other collaborator category [4] 260692 0
Individual
Name [4] 260692 0
Irene Braithwaite
Address [4] 260692 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [4] 260692 0
New Zealand
Other collaborator category [5] 260693 0
Individual
Name [5] 260693 0
Mathew Williams
Address [5] 260693 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [5] 260693 0
New Zealand
Other collaborator category [6] 260694 0
Individual
Name [6] 260694 0
Mark Weatherall
Address [6] 260694 0
MRINZ, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country [6] 260694 0
New Zealand
Other collaborator category [7] 260706 0
Individual
Name [7] 260706 0
Stanislav Tatkov
Address [7] 260706 0
15 Maurice Paykel Place, East Tamaki, Auckland 2013
Country [7] 260706 0
New Zealand
Other collaborator category [8] 260707 0
Individual
Name [8] 260707 0
Sheng Feng
Address [8] 260707 0
15 Maurice Paykel Place, East Tamaki, Auckland 2013
Country [8] 260707 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287025 0
Health and Disability Ethics Committee: Northern Y
Ethics committee address [1] 287025 0
130 Grantham St, Hamilton 3204
Ethics committee country [1] 287025 0
New Zealand
Date submitted for ethics approval [1] 287025 0
12/01/2012
Approval date [1] 287025 0
28/03/2012
Ethics approval number [1] 287025 0
NTY/12/01/008

Summary
Brief summary
The Airvo device has been developed to provide oxygen at high flow rates with positive airway pressure. It is not known, however, how this method of delivery influences carbon dioxide levels in patients at risk of oxygen induced hypercapnia, such as those with chronic obstructive pulmonary disease.

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

Contacts
Principal investigator
Name 34012 0
Address 34012 0
Country 34012 0
Phone 34012 0
Fax 34012 0
Email 34012 0
Contact person for public queries
Name 17259 0
Janine Pilcher
Address 17259 0
MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country 17259 0
New Zealand
Phone 17259 0
+64 4 8050241
Fax 17259 0
+64 4 3895707
Email 17259 0
janine.pilcher@mrinz.ac.nz
Contact person for scientific queries
Name 8187 0
Janine Pilcher
Address 8187 0
MRINZ, Wellinton Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country 8187 0
New Zealand
Phone 8187 0
+64 4 8050241
Fax 8187 0
+64 4 3895707
Email 8187 0
janine.pilcher@mrinz.ac.nz