Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000357752
Ethics application status
Approved
Date submitted
9/02/2022
Date registered
28/02/2022
Date last updated
18/07/2024
Date data sharing statement initially provided
28/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation of particle production whilst using nasal high flow and a surgical mask in adult volunteers to inform the risk of infection to healthcare workers
Scientific title
An investigation of particle production whilst using nasal high flow and a surgical mask in adult volunteers to inform the risk of infection to healthcare workers
Secondary ID [1] 306234 0
None
Universal Trial Number (UTN)
U1111-1274-1690
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory illness 324961 0
Condition category
Condition code
Respiratory 322394 322394 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A member of the research team will fit each participant with a commercially available non-invasive ventilation (NIV) hood attached to a particle counter. Flows of 0, 6, 60 L.min-1 will be administered through a nasal high flow interface i) with and ii) without a surgical mask while the patient is a) breathing, b) speaking and c) coughing.
Readings will be taken for 1 minute per intervention over a single one hour session.
The readings will be taken in a commercial laboratory where a particle counter is available.
A member of the research team will assist the participant throughout to ensure that the protocol is followed
Intervention code [1] 322639 0
Treatment: Devices
Comparator / control treatment
This is a comparison of different flows of nasal high flow with and without a surgical mask. The control is NHF without a mask.
Control group
Active

Outcomes
Primary outcome [1] 330171 0
The primary endpoint is:
Particle number per unit time in the size range 1-5 um in gas expired from the participant measured using an optical particle counter. We will analyse data from the following activities (order to be randomised): 1) Normal breathing, 2) Speaking 3) Coughing at 0, 6, 60L.min-1 with and without a surgical mask with mouth open and closed as composite outcomes.
Timepoint [1] 330171 0
Each measurement will be taken for 1 minute.
Secondary outcome [1] 405125 0
Particle sizes and distribution in gas expired from the participant measured with an optical particle counter.
Timepoint [1] 405125 0
Each measurement will be taken for 1 minute.
Secondary outcome [2] 405183 0
Total particle count per volume in gas expired from the participant measured with an optical particle counter.
Timepoint [2] 405183 0
Each measurement will be taken for 1 minute.
Secondary outcome [3] 405184 0
Total particle count in gas expired from the participant measured with an optical particle counter.
Timepoint [3] 405184 0
Each measurement will be taken for 1 minute.
Secondary outcome [4] 405185 0
Particle density in gas expired from the participant measured with an optical particle counter.
Timepoint [4] 405185 0
Each measurement will be taken for 1 minute.
Secondary outcome [5] 405186 0
Tolerability as measured by the rate and reasons of withdrawal of participants. This will be recorded on the Case Report Form and the participant will be asked his/her reason for withdrawal.
Timepoint [5] 405186 0
End of study

Eligibility
Key inclusion criteria
• Participants 18 years and over
• Capable of informed consent
• Neck size of 34-52 cm (appropriate to NIV hoods available)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Diagnosis of COVID-19 within the last 4 weeks
• Current symptoms of respiratory illness or COVID-19
• Lung disease (e.g. > mild asthma, COPD, Bronchiectasis)
• Mask phobia / claustrophobia
• Conditions that are contraindicated by the manufacturer (Fisher & Paykel Healthcare) for using nasal high flow
• Direct reports of the principal investigator

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Independent statistician
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
We will use standard parametric and non-parametric techniques as appropriate to determine differences between groups. The exact statistical approach will be determined by the independent external statistician. The statistician will be blinded to the interventions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/05/2025
Actual
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
31/07/2026
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 24513 0
New Zealand
State/province [1] 24513 0
Auckland

Funding & Sponsors
Funding source category [1] 310582 0
University
Name [1] 310582 0
University of Auckland
Country [1] 310582 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
The University of Auckland, Private Bag 92019
Auckland 1142, New Zealand
Country
New Zealand
Secondary sponsor category [1] 311958 0
None
Name [1] 311958 0
Address [1] 311958 0
Country [1] 311958 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310188 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 310188 0
Ethics committee country [1] 310188 0
New Zealand
Date submitted for ethics approval [1] 310188 0
01/11/2021
Approval date [1] 310188 0
14/12/2021
Ethics approval number [1] 310188 0
2021 EXP 11244

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

Contacts
Principal investigator
Name 116802 0
Mr Matthew Payton
Address 116802 0
Department of Anaesthesiology,
The University of Auckland,
Private Bag 92019,
Auckland 1142
New Zealand
Country 116802 0
New Zealand
Phone 116802 0
+64 21 774 887
Fax 116802 0
Email 116802 0
[email protected]
Contact person for public queries
Name 116803 0
Matthew Payton
Address 116803 0
Department of Anaesthesiology,
The University of Auckland,
Private Bag 92019,
Auckland 1142
New Zealand
Country 116803 0
New Zealand
Phone 116803 0
+64 21 774 887
Fax 116803 0
Email 116803 0
[email protected]
Contact person for scientific queries
Name 116804 0
Matthew Payton
Address 116804 0
Department of Anaesthesiology,
The University of Auckland,
Private Bag 92019,
Auckland 1142
New Zealand
Country 116804 0
New Zealand
Phone 116804 0
+64 21 774 887
Fax 116804 0
Email 116804 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
According to the ethics approval for this study, de-identified data will be made available to other researchers on request for future research as specified below and / or will be added to data from other sources to form larger datasets:
1. unspecified purposes which are directly related to the study question(s)
2. unspecified purposes which are related to the item and/or condition under study
When will data be available (start and end dates)?
From the publication of results to 10 years after the last participant is enrolled.
Available to whom?
Researchers with appropriate ethical approval
Available for what types of analyses?
1. purposes which are directly related to the study question(s)
2. purposes which are related to the item and/or condition under study
How or where can data be obtained?
By request to the principal investigator: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14819Ethical approval  [email protected]
14820Informed consent form  [email protected]
14821Study protocol  [email protected]



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.