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Trial registered on ANZCTR


Registration number
ACTRN12620000064909p
Ethics application status
Submitted, not yet approved
Date submitted
2/12/2019
Date registered
24/01/2020
Date last updated
24/01/2020
Date data sharing statement initially provided
24/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of rhinothermy on nasopharyngeal temperature
Scientific title
The effect of rhinothermy on nasopharyngeal temperature of healthy volunteers
Secondary ID [1] 299977 0
MRINZ/19/19
Universal Trial Number (UTN)
U1111-1243-7099
Trial acronym
rNHF NP temp
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory viruses 315440 0
Condition category
Condition code
Infection 313737 313737 0 0
Other infectious diseases
Respiratory 313738 313738 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be assigned to either nasal high flow rhinothermy (rNHF) or 'sham' rhinothermy in a fixed order.
Nasal high flow rhinothermy (rNHF) at 41°C involves the delivery of 100% humidified air, heated to 41°C at 35L/min via the rhinothermy device produced by Fisher & Paykel Healthcare.
The rNHF rhinothermy device is a humidifier with integrated flow generator. It draws in room air which is humidified and heated to a set dew point by the device.
Participants will receive their intervention on site either on the same day as the screening visit, or at another arranged appointment. The intervention will be set-up and delivered under supervision of study investigators. Safety checks will be completed by a study investigator on each device before they are provided for use.
Following the five minute baseline monitoring period, the participant will receive their intervention.
During the intervention delivery, nasopharyngeal temperatures will be measured for a minimum of ten minutes each in the following order, whilst:
1. Breathing “normally”
2. Nose breathing
3. Mouth breathing
Each ten minute period includes a minimum of five minutes “run-in” and five minutes “recording”. The nasopharyngeal temperature measured over five minutes during the “recording” period, are the readings that will be included in the results analysis.
Breathing “normally” will be defined as a period when the participant can choose to breathe through their mouth or nose at any time as they choose, and allows talking.
Intervention code [1] 316237 0
Treatment: Devices
Comparator / control treatment
‘Sham’ rhinothermy: 100% humidified air delivered via the myAIRVO 2 device (produced by Fisher and Paykel Healthcare)at 10L/min and 31°C
Control group
Active

Outcomes
Primary outcome [1] 322152 0
Mean nasopharyngeal temperature during delivery of rNHF at 41°C whilst nose breathing as measured by the nasopharyngeal temperature probe.

Nasal endoscopy will be performed by a doctor trained and competent in the procedure. Prior to administering any interventions a doctor will administer local anaesthetic spray to the participant’s nostrils and nasopharynx. Once anaesthetised, a temperature probe (thermistor) will be inserted via the nares into the participant’s nasopharynx by a doctor under direct visualisation using a flexible nasoendoscope. Once the temperature probe position is confirmed in the nasopharynx, there will be a five minute period of monitoring to confirm correct read outs from the temperature probe, and obtain the baseline nasopharyngeal temperature.
Timepoint [1] 322152 0
During the five minute recording period for nose breathing
Secondary outcome [1] 377514 0
The difference in mean nasopharyngeal temperature whilst nose breathing and mouth breathing for each intervention as measured by the nasopharyngeal temperature probe.
Timepoint [1] 377514 0
During the five minute recording periods for nose breathing and mouth breathing
Secondary outcome [2] 377515 0
Mean nasopharyngeal temperature for each intervention whilst breathing “normally” as measured by the nasopharyngeal temperature probe.
Timepoint [2] 377515 0
During the five minute recording period for breathing normally
Secondary outcome [3] 377516 0
Mean nasopharyngeal temperature for each intervention whilst nose breathing as measured by the nasopharyngeal temperature probe.
Timepoint [3] 377516 0
During the five minute recording period for nose breathing
Secondary outcome [4] 377517 0
Mean nasopharyngeal temperature for each intervention whilst mouth breathing as measured by the nasopharyngeal temperature probe.
Timepoint [4] 377517 0
During the five minute recording period for mouth breathing
Secondary outcome [5] 377518 0
Mean baseline nasopharyngeal temperature prior to each intervention as measured by the nasopharyngeal temperature probe.
Timepoint [5] 377518 0
During the five minute baseline recording period prior to intervention delivery
Secondary outcome [6] 377519 0
Mean temperature of the air emitted from the nasal prongs of each intervention as measured by a temperature probe.

Prior to placement of the nasopharyngeal temperature probe, a separate temperature probe will be inserted into one of the nasal prongs attached to the interventional device to allow temperature measurement of the air emitted from the interventional device for five minutes.
Timepoint [6] 377519 0
During the five minute recording period prior to baseline recording

Eligibility
Key inclusion criteria
• Aged 18-75 years inclusive
• In the Investigator’s opinion, is able and willing to comply with all trial requirements
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Any respiratory condition including but not limited to asthma, COPD, bronchiectasis and pulmonary fibrosis

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

• 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

• A notifiable disease e.g. Tuberculosis or Human Immunodeficiency Virus

• Current use of anticoagulant medication

• Previous sinus surgery

• An episode of epistaxis during the last week

• Pre-existing bleeding disorder

• Neurological or neuromuscular conditions which could cause disorders of breathing, swallowing or posture

• Previous allergic reaction to local anaesthetic

• 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.

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Single-centre
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A mixed linear model will be used to estimate the difference between mouth and nose breathing with participants as a random effect. A one-sided t-test will be used to test whether the temperature is within 41°C for the formal assessment of nasopharyngeal temperature.

As there are no similar studies in the literature from which to derive a paired SD, an interim review of the sample size will be carried out after 12 participants (six in each intervention group) have completed the study. This will allow calculation of the paired SD and adjustment of the sample size as indicated.
The SD will be estimated and confidence intervals for the SD by a Chi-square method. A sample size estimate for a one-sided test for a mean temperature of within 1.5°C of 41°C will use a t-test assumption based on the upper and lower confidence interval.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/02/2020
Actual
Date of last participant enrolment
Anticipated
31/05/2020
Actual
Date of last data collection
Anticipated
31/05/2020
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 22159 0
New Zealand
State/province [1] 22159 0
Wellington

Funding & Sponsors
Funding source category [1] 304435 0
Commercial sector/Industry
Name [1] 304435 0
Fisher and Paykel Healthcare Limited
Country [1] 304435 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare Limited
Address
15 Maurice Paykel Place, East Tamaki, Auckland, New Zealand, 2013
Country
New Zealand
Secondary sponsor category [1] 304695 0
None
Name [1] 304695 0
Address [1] 304695 0
Country [1] 304695 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304870 0
Health and Disability Ethics Committees
Ethics committee address [1] 304870 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 304870 0
New Zealand
Date submitted for ethics approval [1] 304870 0
29/11/2019
Approval date [1] 304870 0
Ethics approval number [1] 304870 0

Summary
Brief summary
This is a single-centre, non-randomised, interventional study of 12 healthy, adult participants with continuous measurement of nasopharyngeal temperature during delivery of 100% humidified air via a rhinothermy device at 41°C and 35L/min (rNHF), and 31°C and 10L/min (‘sham’ rhinothermy).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98474 0
Dr Grace Bird
Address 98474 0
Medical Research Institute of New Zealand, Level 7, CSB Building, Wellington Hospital, Newtown, Wellington 6021
Country 98474 0
New Zealand
Phone 98474 0
+64048050244
Fax 98474 0
+64 (04) 3895707
Email 98474 0
[email protected]
Contact person for public queries
Name 98475 0
Grace Bird
Address 98475 0
Medical Research Institute of New Zealand, Level 7, CSB Building, Wellington Hospital, Newtown, Wellington 6021
Country 98475 0
New Zealand
Phone 98475 0
+64048050244
Fax 98475 0
+64 (04) 3895707
Email 98475 0
[email protected]
Contact person for scientific queries
Name 98476 0
Grace Bird
Address 98476 0
Medical Research Institute of New Zealand, Level 7, CSB Building, Wellington Hospital, Newtown, Wellington 6021
Country 98476 0
New Zealand
Phone 98476 0
+64048050244
Fax 98476 0
+64 (04) 3895707
Email 98476 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
Mean data will be available. There will be too much individual data as it will be temperature readings per second during the temperature measurement periods for each individual.


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.