Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000478112
Ethics application status
Approved
Date submitted
19/03/2019
Date registered
22/03/2019
Date last updated
16/07/2021
Date data sharing statement initially provided
22/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of the Rest Activity Cycler-Positive Airway Pressure (RACER-PAP) during exercise in normal healthy adults
Scientific title
RACer–PAP. Investigating the utility and acceptability of the use of a new non invasive ventilatory assist device during exercise in a population of normal healthy adults.
Secondary ID [1] 295384 0
None
Universal Trial Number (UTN)
U1111-1216-5816
Trial acronym
RACer-PAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ventilatory assist 308615 0
Condition category
Condition code
Respiratory 307566 307566 0 0
Normal development and function of the respiratory system
Respiratory 310644 310644 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research will investigate a new non-invasive portable assisted ventilatory device called the RACer-PAP. The RACer-PAP (Rest Activity Cycler-positive airway pressure) works similarly to a Continuous Positive Airways Pressure (CPAP) device (a device which is readily available
for the treatment of people with breathing disorders) by assisting respiration and reducing the work of breathing. CPAP is a widely utilised form of NIV and has been shown to splint open the airways at end expiration, counter intrinsic positive end expiratory pressure (PEEPi - the inspiratory load threshold) and thus reduce the work of breathing (Ambosino & Xie, 2017, Kallet & Diaz, 2009). Use of CPAP during exercise has also demonstrated reduced breathlessness and improved exercise tolerance in patients with COPD (Ambrosino & Xie 2017, O’Donnell, Sanii & Younes, 1988, Petrof, Calderini & Gottfried, 1990). RACer-PAP has previously been safely used and investigated in a number of populations (including in healthy people and in those with sleep apnoea) but has not yet been tested during exercise.

The RACer-PAP uses nasal pillows to deliver CPAP through the nostrils and accommodates to the individuals nasal breathing cycle, regulating the amount of air that passes through each nostril. The nasal breathing cycle is not fully understood; however, it is thought that, under usual circumstances, one nostril allows more airflow to pass through than the other, the flow alternating between nostrils approximately every three hours (White, Bartley & Nates, 2015). This is caused by periodic unilateral obstruction by turbinate hypertrophy and is believed to aid in the removal of contaminants (White, Bartley & Nates, 2015). The RACer–PAP determines the dominant nostril for each individual within its first few assisted breaths, and after this the device ramps up to an operator determined pressure to ensure that the dominant nostril receives a higher pressure than the non-dominant nostril. A positive end expiratory pressure is adjusted to each patient’s comfort level (6-20 cm H2O). This continues for a pre-set time, then switches so the other nostril receives the higher pressure. This cycle continues for the time determined by the therapist to assist the patient with breathing. It is important that the pressure is adjustable to accommodate each patient's PEEPi which is influenced by the compliance of the individual’s lungs (Kallet & Diaz, 2009). RACer-PAP has been shown to reduce dryness in nose, mouth and throat compared to CPAP with supplementary humidification which is non-portable (Neill & Campbell, 2017). Thus RACer-PAP eliminates the need for supplementary humidification and offers the convenience of treatment portability. Additionally, the device can deliver up to 73 liters a minute of room air through each of the hoses (per nostril) ensuring that the device is able to meet the air flow demands of participants even during exercise.

Fifteen healthy volunteers will individually attend two sessions at AUT university a maximum of one week apart. Both sessions will be at the same time of day (or within an hour). Sessions will last up to 1.5 hours each.
Two healthcare professionals (one of whom is from the research team and a qualified physiotherapist with a minimum of 10 years experience in chronic lung disease management) will be present at each session.
Session 1.
Informed consent will be ascertained and a widely used exercise risk assessment tool (PAR-Q) will be completed by the participant. If this is positive, an extended exercise risk assessment tool (ePARmed-X+) will be used to determine if the participant requires referral to a medical professional for exercise clearance. If ePARmed-X+ is positive, participants will be excluded.
Baseline screening of vital signs (heart rate, blood pressure, oxygen saturation).
Baseline breathing testing (spirometry) will be undertaken. A test six minute walk test (6MWT) will be undertaken.This is followed by 30 minutes rest then a test 6MWT will be undertaken (see protocol in Step 11).
Following return to baseline status after the test 6MWT, the RACer-PAP will be applied to the participant to be worn at rest for 10 minutes at a participant determined ventilatory comfortable level.
Spirometry and vital signs will be undertaken immediately following RACer-PAP removal.A RACer-PAP questionnaire will be undertaken following removal.
End of session 1.

Session 2
Baseline testing of vital signs and spirometry (as session 1 above).
Randomisation of order of RACer-PAP testing as below via via computer generated numbers stored in sealed envelopes:

1. 6MWT with RACer-PAP in situ during exercise
2. RACer-PAP worn at rest for 10 minutes, removed and, immediately following removal the participant undertakes a 6MWT

Procedure at session 2.
6MWT 1 or 2 (followed immediately by spirometry and vital sign measures)
30 minutes rest
6MWT 1 or 2 (followed immediately by spirometry and vital sign measures) RACer-PAP questionnaire 2 undertaken. End of session.
No risks to participation are anticipated. 6MWTs are self administered sub maximal walking tests where participants can stop and start activity as they determine necessary. Such walking tests are safely and widely used in both healthy populations and in populations with health and disability problems. The RACER-PAP has been shown to be safe in healthy populations and in those with sleep apnoea. Testing will take part in a clinical environment with standard emergency equipment available.
Intervention code [1] 312817 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319490 0
6 minute walk test distance
Timepoint [1] 319490 0
Over 2 episodes 1 week apart
Secondary outcome [1] 368421 0
FEV1 assessed by spirometry
Timepoint [1] 368421 0
Over 2 episodes 1 week apart
Secondary outcome [2] 368422 0
Purpose designed comfort and utility questionnaire
Timepoint [2] 368422 0
Over 2 episodes 1 week apart
Secondary outcome [3] 368497 0
Heart rate assessed by Welsh Allen Vita signs monitor
Timepoint [3] 368497 0
over 2 episodes 1 week apart
Secondary outcome [4] 368498 0
Borg Dyspnoea scale
Timepoint [4] 368498 0
Over 2 episodes 1 week apart
Secondary outcome [5] 368540 0
FVC assessed by spirometry
Timepoint [5] 368540 0
2 episodes 1 week apart
Secondary outcome [6] 368541 0
FEV1/FVC assessed by spirometry
Timepoint [6] 368541 0
2 episodes 1 week apart
Secondary outcome [7] 368542 0
Blood pressure assessed by Welsh Allen Vita signs monitor
Timepoint [7] 368542 0
2 episodes 1 week apart
Secondary outcome [8] 368543 0
Oxygen saturation assessed by Welsh Allen Vita signs monitor
Timepoint [8] 368543 0
2 episodes 1 week apart

Eligibility
Key inclusion criteria
A group of volunteers from the healthy population will be tested prior to developing a future study which will aim to test people with chronic lung disease.
Inclusion criteria are therefore:
1. Healthy volunteers over the age of 30.
2. Healthy participants will purposively selected to be age, gender, ethnicity and BMI matched to that of the COPD population to be tested in future studies . Selection of participants will be based on:
3. Volunteers availability to attend the two scheduled sessions.
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Potential participants will be excluded if they suffer from or have been diagnosed with;
1. facial deformities
2, nasal polyps or turbinate abnormalities such as sinus infection or other conditions that may influence nasal airflow regulation.
3. heart disease
4. hypertension
5. any respiratory disease,
6. any illness or injury that impairs physical performance
7. any ongoing infection
In addition participants will be excluded if:
1. unable to tolerate the RACer-PAP nasal pillow or mask due to pain or discomfort.
2. positive PAR-Q and ePARmed-X+ (a clearance for exercise risk assessment tool)
3. advised by a medical practitioner to avoid exercise
Participants must be a non-smoker for at least 5 years to reduce the risk of undiagnosed lung pathology.
Anyone identified at first spirometry measurement as having a FEV1/FVC of less than 70% will be excluded.
Due to financial restrictions we are unable to provide translators for this study, therefore anyone who does not understand written or spoken English will be excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
Qualitative analysis of the acceptability and comfort of the devices will be determined by questionnaire addressing issues such as objective pressure, mask/mouthpiece fit, device weight and dryness experienced both at rest and on exercise.
As this is a small feasibility study (n=15), the only reason to conduct statistical testing is to get a measure of variance and within subject differences. Data will be analysed for within subject differences using basic statistical tests of relationship and difference e.g. correlational analyses, t-tests or nonparametric equivalent (Wilcoxon Mann-Whitney U) as appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2019
Actual
20/01/2020
Date of last participant enrolment
Anticipated
28/06/2019
Actual
15/12/2020
Date of last data collection
Anticipated
5/07/2019
Actual
22/12/2020
Sample size
Target
15
Accrual to date
Final
15
Recruitment outside Australia
Country [1] 21351 0
New Zealand
State/province [1] 21351 0
auckland

Funding & Sponsors
Funding source category [1] 299976 0
University
Name [1] 299976 0
AUT University
Country [1] 299976 0
New Zealand
Primary sponsor type
University
Name
AUT university
Address
Po Box 92006
Auckland 1020
Country
New Zealand
Secondary sponsor category [1] 302148 0
None
Name [1] 302148 0
Address [1] 302148 0
Country [1] 302148 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300834 0
Northern B Health and Disability Committee
Ethics committee address [1] 300834 0
Ethics committee country [1] 300834 0
New Zealand
Date submitted for ethics approval [1] 300834 0
03/12/2018
Approval date [1] 300834 0
18/03/2019
Ethics approval number [1] 300834 0
18/NTB/191

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84966 0
Dr Julie Reeve
Address 84966 0
School of Clinical Sciences
Faculty of Health and Environmental Studies
AUT University
Auckland 0627
Country 84966 0
New Zealand
Phone 84966 0
+64 9 9219999 ext 7085
Fax 84966 0
Email 84966 0
[email protected]
Contact person for public queries
Name 84967 0
Julie Reeve
Address 84967 0
School of Clinical Sciences
Faculty of Health and Environmental Studies
AUT University
Auckland 0627
Country 84967 0
New Zealand
Phone 84967 0
+64 9 9219999 ext 7085
Fax 84967 0
Email 84967 0
[email protected]
Contact person for scientific queries
Name 84968 0
Julie Reeve
Address 84968 0
School of Clinical Sciences
Faculty of Health and Environmental Studies
AUT University
Auckland 0627
Country 84968 0
New Zealand
Phone 84968 0
+64 9 9219999 ext 7085
Fax 84968 0
Email 84968 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual identifiable results will be available from this study to protect confidentialiy and anonymity.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1658Study protocol    375477-(Uploaded-20-03-2019-10-29-19)-Study-related document.docx
1659Informed consent form    375477-(Uploaded-19-03-2019-13-26-52)-Study-related document.docx
1661Ethical approval    375477-(Uploaded-19-03-2019-13-27-52)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.