Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000853842
Ethics application status
Approved
Date submitted
28/05/2021
Date registered
2/07/2021
Date last updated
22/11/2022
Date data sharing statement initially provided
2/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Tolerability of inhaled, humidified air at two temperatures (41 and 45 degrees Celsius) in healthy participants
Scientific title
Tolerability study of rhinothermy in healthy participants delivered by nasal high flow therapy (rNHF) at 41°Celsius and 45°Celsius
Secondary ID [1] 304218 0
Nil known
Universal Trial Number (UTN)
UTN: U1111-1264-8556
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper Respiratory Tract Infection 321918 0
Condition category
Condition code
Respiratory 319644 319644 0 0
Other respiratory disorders / diseases
Infection 320141 320141 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three visits per subject (visits one and two may be combined at the subject request). Visits will be undertaken in person at the Medical Research Institute of New Zealand. Participants will be shown the device and the nasal cannula that is used for delivery of the intervention. They will be given the option of placing the nasal cannula on themselves or requesting the study investigator or co-ordinator to place it. All MRINZ staff delivering the intervention will be trained in device operation. During the course of the intervention a study investigator will be present observing the participant to ensure that the cannula are placed correctly and to monitor the device to ensure it is working correctly.

Participants will be randomised 1:1 to one of two groups, intervention or comparator.

Intervention: One continuous session of rhinothermy (rNHF) with 100% humidified air delivered via the rNHF (Fisher & Paykel AIRVO 3) device at 35L/min at 41o Celsius (C) for sixty minutes

The intervention may be stopped at any time by the participant.

An outline of the visits and interventions are supplied below:

Visit 1:
1. Written informed consent with collection of demographic data, medical and surgical history, concomitant medications and allergies, vital signs (heart rate, blood pressure, oxygen saturation and temperature) and a limited physical examination (chest, nose and throat).
2. Assessment for eligibility

Visit 2 (may be at the same time as Visit 1):
1. Reassessment of eligibility criteria and re-examination of the nose and throat prior to randomisation (ONLY if Visit 2 on a separate day to Visit 1).
2. Randomisation to Intervention or Comparator.
3. Delivery of Intervention or Comparator for a period of sixty minutes.
4. Questionnaire indicating reason for stopping intervention or comparator prior to sixty minutes (if applicable)
5. Questionnaire indicating tolerability of intervention and comparator.
6. Post-intervention/comparator examination of the nose and throat.

Visit 3:
1. Examination of the nose and throat.
2. Review for any adverse events.
Intervention code [1] 320555 0
Treatment: Devices
Comparator / control treatment
One continuous session of rNHF with 100% humidified air delivered via the rNHF (Fisher & Paykel AIRVO 3) device at 35L/min at 45oC for sixty minutes.

This is identical in frequency, duration and administration to the intervention, excluding the temperature of the humidified air.
Control group
Active

Outcomes
Primary outcome [1] 327507 0
Proportion of participants in each intervention/comparator group who could not tolerate rNHF for sixty minutes, as determined by review of the study database for the number of participants who stopped treatment prior to sixty minutes
Timepoint [1] 327507 0
Up to 60 minutes post commencement of intervention (Time 0)
Secondary outcome [1] 395446 0
Adverse event rate in each intervention group (narrative description, examination where indicated e.g. dizziness reported, blood pressure (BP) measurement)
Timepoint [1] 395446 0
Up to 18- 24 hours post intervention commencement (Time 0)
Secondary outcome [2] 395447 0
Serious adverse event rate in each intervention group (narrative description, examination where indicated)
Timepoint [2] 395447 0
Up to 18-24 hours post intervention commencement (Time 0)
Secondary outcome [3] 395448 0
Treatment related adverse event rate (attributed by investigator as likely to be related to intervention if there is reasonable possibility of a causal relationship)
Timepoint [3] 395448 0
Up to 18-24 hours post intervention commencement (Time 0)
Secondary outcome [4] 395449 0
Time in minutes to cannula removal/tube disconnection in each intervention arm, assessed by start and stop times recorded in REDCap study database by the study investigator
Timepoint [4] 395449 0
Up to 60 minutes post commencement of intervention (Time 0)
Secondary outcome [5] 395450 0
Time in minutes to any adverse event in each intervention arm, reported to study investigator at time of occurrence and recorded in the REDCap study database
Timepoint [5] 395450 0
Up to 60 minutes post commencement of intervention (Time 0)
Secondary outcome [6] 395451 0
Proportion of participants who stopped their intervention early for each of the identified categories on the discontinuation questionnaire, adapted form previous rhinothermy studies undertaken by the Medical Research Institute of New Zealand for the purpose of this study
Timepoint [6] 395451 0
Within 30 minutes post-intervention completion
Secondary outcome [7] 395452 0
Intervention tolerability questionnaire results, adapted form previous rhinothermy studies undertaken by the Medical Research Institute of New Zealand for the purpose of this study
Timepoint [7] 395452 0
Within 30 minutes post-intervention completion

Eligibility
Key inclusion criteria
Twenty healthy participants aged 18 to 75 years who are in the Investigator’s opinion, able and willing to comply with all study requirements.
Two weeks post full vaccination against SARS-CoV-2 (COVID-19); may either be New Zealand based COMINARTY (Pfizer BioNTech) or administration of equivalent vaccination
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Upper respiratory tract infection (sore throat, cough, rhinorrhoea and/or fever (subjective of objective) within the last fourteen days

Chronic respiratory illness currently being treated e.g. asthma

Nasopharyngeal conditions such as a deviated septum and acute/chronic rhinitis, which the investigator considers could impair nasal breathing

Use of nasal sprays within the last seven days

Current smoker, defined as someone who has smoked or vaped within the last 28 days

Current use of or requirement of oral antibiotics for a respiratory tract infection, pneumonia or infective exacerbation of an underlying respiratory condition

Current use of or requirement of parenteral antibiotics

Have an implantable medical device

Have any other condition which, at the investigator’s discretion, is believed may present a safety risk to the participant or others, or impact the study results or the feasibility of the study.

Previous enrolment in any trials investigating the use of rhinothermy.

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)
Participants will be allocated to an intervention group through the use of a central randomisation sequence generated and entered into the RedCAP system. An unblinded investigator will access the randomisation allocation and set up the device for the correct intervention prior to the start of delivery. The participant and study-investigator will be blinded to the intervention arm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computerised randomisation sequence will be generated by the study statistician and entered into the RedCAP system which is accessed only by the unblinded investigator who will be responsible for allocation to Intervention A or B.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
This study will enrol 20 participants. This size study has reasonable precision to estimate the standard deviation of discontinuation of treatment and will give a margin of error for a proportion of plus or minus approximately 20%; which we regard as a reasonable precision for estimation of the proportion of participants who can tolerate the treatment for one hour.

Statistical analyses will use the intention to treat principle. For dichotomous outcomes comparisons of proportions will be by estimation of relative risk and by Fishers exact test. For Likert-scale variables ordinal regression will be used to estimate the odds of a higher (better) compared to lower score on the Likert scales. For continuous variables data summaries will include mean, standard deviation (SD), median and inter-quartile range (IQR) and minimum to maximum values. In general, continuous variables will be paired by independent t-tests however time to event data will also be compared by Kaplan-Meier curves and estimation of Hazard ratios by Cox Regression.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/12/2021
Actual
26/01/2022
Date of last participant enrolment
Anticipated
30/06/2022
Actual
16/06/2022
Date of last data collection
Anticipated
4/07/2022
Actual
17/06/2022
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 23705 0
New Zealand
State/province [1] 23705 0
Wellington

Funding & Sponsors
Funding source category [1] 308595 0
Commercial sector/Industry
Name [1] 308595 0
Fisher & Paykel Healthcare Limited
Country [1] 308595 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare Limited
Address
15 Maurice Paykel Place
East Tamaki
Auckland 2013
New Zealand
Country
New Zealand
Secondary sponsor category [1] 309454 0
None
Name [1] 309454 0
Address [1] 309454 0
Country [1] 309454 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308529 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 308529 0
Ethics committee country [1] 308529 0
New Zealand
Date submitted for ethics approval [1] 308529 0
02/06/2021
Approval date [1] 308529 0
17/06/2021
Ethics approval number [1] 308529 0
21/CEN/148

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

Contacts
Principal investigator
Name 111026 0
Dr Karen Oldfield
Address 111026 0
Medical Research Institute of New Zealand
Level 7, CSB Building
Wellington Hospital
Riddiford Street
Newtown 6021
Wellington
Country 111026 0
New Zealand
Phone 111026 0
+64 4 805 0147
Fax 111026 0
Email 111026 0
[email protected]
Contact person for public queries
Name 111027 0
Karen Oldfield
Address 111027 0
Medical Research Institute of New Zealand
Level 7, CSB Building
Wellington Hospital
Riddiford Street
Newtown 6021
Wellington
Country 111027 0
New Zealand
Phone 111027 0
+64 4 805 0147
Fax 111027 0
Email 111027 0
[email protected]
Contact person for scientific queries
Name 111028 0
Karen Oldfield
Address 111028 0
Medical Research Institute of New Zealand
Level 7, CSB Building
Wellington Hospital
Riddiford Street
Newtown 6021
Wellington
Country 111028 0
New Zealand
Phone 111028 0
+64 4 805 0147
Fax 111028 0
Email 111028 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 participant data will be available due to commercial senstivity.


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
No additional documents have been identified.