ANZCTR - Registration

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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]

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)

Condition category

Condition code

Respiratory

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]

Treatment: Devices

Comparator / control treatment

Control group

Active

Outcomes

Primary outcome [1]

Respiratory rate

Timepoint [1]

*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]

Gas exchange

Timepoint [2]

*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]

Tidal volume and end expiratory lung volume

Timepoint [3]

*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]

Subjective scoring of dyspnoea

Timepoint [1]

*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]

Subjective score of comfort

Timepoint [2]

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

Sex

Males

Can healthy volunteers participate?

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

10/04/2012

Actual

10/04/2012

Date of last participant enrolment

Anticipated

Actual

5/05/2014

Date of last data collection

Anticipated

Actual

5/05/2014

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

The Prince Charles Hospital - Chermside

Recruitment postcode(s) [1]

4032 - Chermside

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Fisher and Paykel Healthcare

Address [1]

15 Maurice Paykel Place,
East Tamaki.
Auckland.
1741

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Prince Charles Hospital Human Research and Ethics Committee

Ethics committee address [1]

Rode Rd,
Chermside.QLD. 
4032

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

21/11/2011

Ethics approval number [1]

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

Prof John Fraser

Address

The Prince Charles Hospital,
Rode Rd,
Chermside. QLD.
4032

Country

Australia

Phone

+61 7 3139 4000

Fax

+ 61 7 3139 6140

john_fraser@health.qld.gov.au

Contact person for public queries

Name

India Lye

Address

Room 15, Level 3, Clinical Sciences Building
The Prince Charles Hospital
Rode Road,
Chermside, Queensland, 4032

Country

Australia

Phone

+61 7 3139 5089

Fax

N/A

india.lye@health.qld.gov.au

Contact person for scientific queries

Name

Amanda Corley

Address

Room 15, Level 3, Clinical Sciences Building
The Prince Charles Hospital
Rode Road,
Chermside, Queensland, 4032

Country

Australia

Phone

+61 7 3139 5772

Fax

N/A

amanda.corley@health.qld.gov.au

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

Source	Title	Year of Publication	DOI
Dimensions AI	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	2016	https://doi.org/10.1136/thoraxjnl-2015-207962
Embase	Efficiency of High-Flow Nasal Cannula on Pulmonary Rehabilitation in COPD Patients: A Meta-Analysis.	2020	https://dx.doi.org/10.1155/2020/7097243

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

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