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Trial registered on ANZCTR


Registration number
ACTRN12613000028707
Ethics application status
Approved
Date submitted
18/12/2012
Date registered
10/01/2013
Date last updated
2/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of heated humidified high flow oxygen (AIRVO) in patients with chronic obstructive pulmonary disease
Scientific title
The use of heated humidified high flow oxygen (AIRVO) as an adjunct to conventional oxygen delivery systems in patients with chronic obstructive pulmonary disease
Secondary ID [1] 281690 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease (COPD)
287979 0
Condition category
Condition code
Respiratory 288362 288362 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In a randomised crossover study patients will be studied on their usual home oxygen (Control) and on AIRVO (Treatment).

Treatment
* Patient receives usual home oxygen while equipment is set up (20 minutes)
* Baseline observations on usual home oxygen will be recorded (20 minutes)
* Participant receives treatment/control (20 minutes)
* Washout period on usual home oxygen (20 minutes)
* Participant receives treatment/control (20 minutes)
* Recovery period on usual home oxygen (20 minutes)

Note:
*Usual home oxygen - patient receives the usual oxygen flow rate received at home via their own cannulae
*AIRVO - oxygen flow into the Airvo system is titrated to give an oxygen saturation the same as the patient receives on their own cannulae along with a flow of 30L/min
Intervention code [1] 286227 0
Treatment: Devices
Comparator / control treatment
In a randomised crossover study patients will be studied on their usual home oxygen (Control) and on AIRVO (Treatment).

Treatment
* Patient receives usual home oxygen while equipment is set up (20 minutes)
* Baseline observations on usual home oxygen will be recorded (20 minutes)
* Participant receives treatment/control (20 minutes)
* Washout period on usual home oxygen (20 minutes)
* Participant receives treatment/control (20 minutes)
* Recovery period on usual home oxygen (20 minutes)

Note:
*Usual home oxygen - patient receives the usual oxygen flow rate received at home via their own cannulae
*AIRVO - oxygen flow into the Airvo system is titrated to give an oxygen saturation the same as the patient receives on their own cannulae along with a flow of 30L/min
Control group
Active

Outcomes
Primary outcome [1] 288531 0
Respiratory rate
Timepoint [1] 288531 0
*Respiratory rate will be measured via the respiratory rate on the electrical impedance tomograph
*Respiratory rate is measured at baseline and then at 5 mins and 15 mins within each 20 min period
Primary outcome [2] 288588 0
Gas exchange
Timepoint [2] 288588 0
*An oxygen saturation probe will measure oxygen saturation and a transcutaneous oximeter will calculate carbon dioxide and oxygen levels
* Oxygen saturation, transcutaneous carbon dioxide and oxygen levels are calculated at baseline and then at 5 mins and 15 mins within each 20 min period
Primary outcome [3] 288589 0
Tidal volume and end expiratory lung volume
Timepoint [3] 288589 0
*Respiratory inductive plethysmography will be used to measure tidal volume and electrical impedance tomography will be used to measure end expiratory lung impedance
* This data is collected at baseline and at the end of each 20 min period for 2 mins
Secondary outcome [1] 300398 0
Subjective scoring of dyspnoea
Timepoint [1] 300398 0
*Dyspnoea scores will be calculated using a Visual analogue scale (0-10)
* Patients will also be asked to score their dyspnoea level at baseline and at 15 mins in each 20 min period
Secondary outcome [2] 300543 0
Subjective score of comfort
Timepoint [2] 300543 0
Patients will be asked to score their comfort using a Visual analogue scale (0-10) on usual home oxygen and on AIRVO

Eligibility
Key inclusion criteria
* Male COPD patients requiring home oxygen
* Formal spirometry data less than one year old
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Co-morbidities that may effect respiratory function or physiological measurements
* Active respiratory infection on day of study
* Frequent pursed-lip breathing
* Anxiousness about breathing with a system different to their current one


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)
Patients will be enrolled via telephone consent and randomly allocated to receive the control (usual home oxygen) or treatment (AIRVO) first. Following the washout period the participant will receive the alternate arm control/treatment. Identical numbered opaque sealed envelopes containing the randomisation order will be prepared by non study staff. It will not be possible to blind the patient, clinical staff or study staff to the treatment allocation. The statistician will be blinded to treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a table created by computer software will be generated. Identical numbered opaque sealed envelopes containing the randomisation order will be prepared by non study staff. The randomisation order will be revealed immediately prior to study commencement.
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)
Efficacy
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 in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 324 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 6129 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 286481 0
Commercial sector/Industry
Name [1] 286481 0
Fisher and Paykel Healthcare
Address [1] 286481 0
15 Maurice Paykel Place,
East Tamaki.
Auckland.
1741
Country [1] 286481 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
Critical Care Research Group, The Prince Charles Hospital
Address
Room 15, Level 3, Clinical Sciences Building
The Prince Charles Hospital
Rode Road
Chermside, Queensland, 4032
Country
Australia
Secondary sponsor category [1] 285271 0
None
Name [1] 285271 0
Address [1] 285271 0
Country [1] 285271 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288558 0
The Prince Charles Hospital Human Research and Ethics Committee
Ethics committee address [1] 288558 0
Rode Rd,
Chermside.QLD.
4032
Ethics committee country [1] 288558 0
Australia
Date submitted for ethics approval [1] 288558 0
Approval date [1] 288558 0
21/11/2011
Ethics approval number [1] 288558 0
HREC/11/QPCH/152

Summary
Brief summary
Chronic obstructive pulmonary disease (COPD) is a leading cause of death worldwide. In addition to generating high healthcare costs, COPD imposes a significant burden in terms of disability and impaired quality of life. Unlike many leading causes of death and disability, COPD is projected to increase in much of the world as smoking frequencies rise and the population ages.

The use of home oxygen for hypoxic COPD patients has increased since studies have shown improved survival. Home oxygen however is cold and dry and may be uncomfortable and lead to thickened secretions.

This study aims to assess the feasibility and short term physiological respiratory changes caused by using an alternative device AIRVO (high flows of warmed and humidified air enriched oxygen ) versus the currently used home oxygen (low flow oxygen therapy).
Trial website
Trial related presentations / publications
Dunster, KR., Corley, A., Spooner, AJ., Fraser, JF. (2013). The use of heated humidified high flow oxygen (AIRVO) in patients with COPD. American Thoracic Society Conference 2013. Philadelphia, USA.

Fraser, JF., Spooner, AJ., Dunster, KR., Anstey, CA., Corley, A. (2016). Nasal high flow oxygen therapy in patients with COPD reduces respiratory rate and tissue carbon dioxide while increasing tidal and end-expiratory lung volumes: a randomised crossover trial. Thorax, 71(8), 759-761.
Public notes

Contacts
Principal investigator
Name 36674 0
Prof John Fraser
Address 36674 0
The Prince Charles Hospital,
Rode Rd,
Chermside. QLD.
4032
Country 36674 0
Australia
Phone 36674 0
+61 7 3139 4000
Fax 36674 0
+ 61 7 3139 6140
Email 36674 0
john_fraser@health.qld.gov.au
Contact person for public queries
Name 36675 0
Ms India Lye
Address 36675 0
Room 15, Level 3, Clinical Sciences Building
The Prince Charles Hospital
Rode Road,
Chermside, Queensland, 4032
Country 36675 0
Australia
Phone 36675 0
+61 7 3139 5089
Fax 36675 0
N/A
Email 36675 0
india.lye@health.qld.gov.au
Contact person for scientific queries
Name 36676 0
Ms Amanda Corley
Address 36676 0
Room 15, Level 3, Clinical Sciences Building
The Prince Charles Hospital
Rode Road,
Chermside, Queensland, 4032
Country 36676 0
Australia
Phone 36676 0
+61 7 3139 5772
Fax 36676 0
N/A
Email 36676 0
amanda.corley@health.qld.gov.au

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