Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000235606p
Ethics application status
Not yet submitted
Date submitted
21/02/2023
Date registered
6/03/2023
Date last updated
6/03/2023
Date data sharing statement initially provided
6/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of asymmetrical nasal high flow therapy on nasal airflow
Scientific title
Effect of asymmetric nasal high flow therapy on nasal patency in healthy adults
Secondary ID [1] 309046 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory disease 329101 0
Condition category
Condition code
Respiratory 326075 326075 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nasal high flow therapy (NHF) will be applied using an Airvo 3 unit (Fisher & Paykel Healthcare, New Zealand) for three hours via a nasal cannula with symmetrical prongs (current standard of care method; intervention 1) or a new, asymmetrically pronged cannula (intervention 2). The size of the prongs used will be determined by the size of the participants nostrils. The diameter of left prong of the asymmetrical nasal cannula is increased, and the right prong decreased, compared to the standard symmetrical nasal cannula. For NHF therapy, participants will sit at rest while humidified, 37°C air is pumped through the prongs at 30 L/min to provide positive airway pressure. Participants will be supervised by research staff for the duration of each visit. Visits will occur on three consecutive days, at the same time of day.
Intervention code [1] 325488 0
Treatment: Devices
Comparator / control treatment
Participants will breathe room air (no NHF therapy) without a nasal cannula for 3 hours, while sitting at rest.
Control group
Active

Outcomes
Primary outcome [1] 333939 0
Nasal, oral resistance and total resistance: This will be measured using a pressure transducer and flow head, and assessed as a composite outcome.
Timepoint [1] 333939 0
Resistance will be measured before NHF therapy/control (baseline), and after three hours (post).
Primary outcome [2] 333940 0
Nasal volume will be performed using acoustic rhinometry
Timepoint [2] 333940 0
Nasal volume will be measured before NHF therapy/control (baseline), and after three hours (post).
Secondary outcome [1] 418803 0
Self reported nasal patency will be assessed via a questionnaire asking participants to rate how patent they feel their nostrils are
Timepoint [1] 418803 0
The questionnaire will be administered before NHF therapy/control (baseline), and after three hours (post).
Secondary outcome [2] 418804 0
Nasal temperature will be assessed using a thermocouple placed inside the nostrils.
Timepoint [2] 418804 0
Pressure will be measured continuously during the 3 hour intervention period
Secondary outcome [3] 419038 0
Pressure inside the nostrils will be measured using a pressure transducer.
Timepoint [3] 419038 0
Pressure will be measured continuously throughout the 3 hour intervention period.

Eligibility
Key inclusion criteria
Participants must be healthy, aged between 18 and 35 years and free of nasal/upper airway pathophysiology.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if:
- They have any allergies
- They have recently (in the last month) had any illness or infection.
- They have ever had any surgery or trauma to their nose.
- They suffer from asthma or any other respiratory disease.
- They have ever been told that they snore loudly.
- They have been told that they stop breathing during their sleep.
- They have a deviated septum.
- They have difficulty breathing through their nose.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Repeated measures ANOVA will be carried out to investigate changes over time (pre vs post) and differences between conditions (symmetrical vs asymmetrical vs control). Post hoc anlysis with Bonferroni adjustment will be made when main effects are found. Statistcal significance will be set at p < 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/03/2023
Actual
Date of last participant enrolment
Anticipated
16/09/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 25279 0
New Zealand
State/province [1] 25279 0
Manawatu

Funding & Sponsors
Funding source category [1] 313249 0
Commercial sector/Industry
Name [1] 313249 0
Fisher & Paykel Healthcare Ltd
Country [1] 313249 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Tennant Drive
Palmerston North 4410
New Zealand
Country
New Zealand
Secondary sponsor category [1] 314981 0
None
Name [1] 314981 0
Address [1] 314981 0
Country [1] 314981 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 312481 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 312481 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 312481 0
New Zealand
Date submitted for ethics approval [1] 312481 0
17/03/2023
Approval date [1] 312481 0
Ethics approval number [1] 312481 0

Summary
Brief summary
Nasal high flow (NHF) therapy is an intervention used when combatting respiratory failure and is standard of care. NHF provides respiratory support, via nasal prongs and air flow directed up the nostrils, leading to lung dead space clearance and, additionally, supplemental oxygen can be given if required. While commonly used, the effect of this therapy on the upper airway is not fully understood.
In healthy individuals, the openness (patency) of each individual nostril changes throughout the day/night by engorgement of nasal erectile tissue, this is called the nasal cycle. This is thought to be involved in airway humidification and airborne pathogen handling.
In this study we want to understand the effect NHF can have on the nasal cycle with two modalities of NHF delivery; via the currently standard nasal cannula with symmetrical prongs and a new interface with asymmetrical prongs.
Benchtop experiments have shown that NHF delivered via asymmetrical prongs may be better at dead space clearance (Tatkov et al. 2023), but we have little understanding how this will affect the upper airway physiology.
As such we plan to compare the effects of symmetrical and asymmetrical prongs on the nasal cycle and patency.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124814 0
A/Prof Matthew J Barnes
Address 124814 0
School of Sport, Exercise & Nutrition
Practical Teaching Complex
Massey University
Palmerston North 4410
Country 124814 0
New Zealand
Phone 124814 0
+6463569099
Fax 124814 0
Email 124814 0
m.barnes@massey.ac.nz
Contact person for public queries
Name 124815 0
A/Prof Matthew J Barnes
Address 124815 0
School of Sport, Exercise & Nutrition
Practical Teaching Complex
Massey University
Palmerston North 4410
Country 124815 0
New Zealand
Phone 124815 0
+6463569099
Fax 124815 0
Email 124815 0
m.barnes@massey.ac.nz
Contact person for scientific queries
Name 124816 0
A/Prof Matthew J Barnes
Address 124816 0
School of Sport, Exercise & Nutrition
Practical Teaching Complex
Massey University
Palmerston North 4410
Country 124816 0
New Zealand
Phone 124816 0
+6463569099
Fax 124816 0
Email 124816 0
m.barnes@massey.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be analysed and reported as means and standard deviations.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18396Study protocol  m.barnes@massey.ac.nz
18398Informed consent form  m.barnes@massey.ac.nz
18399Ethical approval  m.barnes@massey.ac.nz



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.