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Trial registered on ANZCTR


Registration number
ACTRN12622001278729
Ethics application status
Approved
Date submitted
20/09/2022
Date registered
29/09/2022
Date last updated
2/12/2022
Date data sharing statement initially provided
29/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Transcutaneous Oxygen and Nasal High Flow in healthy adults
Scientific title
Transcutaneous oxygen and Nasal High flow: a prospective, interventional, crossover, randomised, feasibility study investigating the effect of nasal high flow oxygen delivery on transcutaneous oxygen partial pressure in healthy adults
Secondary ID [1] 308005 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesia 327677 0
Condition category
Condition code
Anaesthesiology 324761 324761 0 0
Other anaesthesiology
Respiratory 324784 324784 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
100% oxygen delivered at 70 L/min via nasal high flow until transcutaneous oxygen partial pressure (TcO2) plateau or 30 minutes maximum, whichever occurs first. This will be followed by a washout period until TcO2 returns to baseline or 1 hour maximum, whichever occurs first. Adherence will be monitored by direct supervision for the duration of the intervention by a member of the study team.

Participants will be in a resting state and instructed to breath normally for the duration of the study maintaining a rate of approximately 10-12 breaths per minute. Participants will be given the first flow rate for 30 minutes or until TcO2 reaches a plateau, whichever occurs first. A plateau is defined as when TcO2 increases by no more than 1 kPa over 5 minutes. Nasal high flow will then be stopped and TcO2 will be monitored until TcO2 returns to baseline (+/- 1kPa), whichever occurs first. Then the process will be repeated with the second flow rate. All interventions will be administered by a research doctor and the study will be conducted at an onsite clinic at Fisher & Paykel Healthcare.
Intervention code [1] 324457 0
Treatment: Devices
Comparator / control treatment
100% oxygen delivered at 10 L/min via nasal high flow until transcutaneous oxygen partial pressure (TcO2) plateau or 30 minutes maximum, whichever occurs first. This will be followed by a washout period until TcO2 returns to baseline or 1 hour maximum, whichever occurs first. Adherence will be monitored by direct supervision for the duration of the intervention by a member of the study team. The first flow rate and second flow rate will have a washout period in between (1 hour maximum or until TcO2 returns to baseline, whichever occurs first).

Participants will be in a resting state and instructed to breath normally for the duration of the study maintaining a rate of approximately 10-12 breaths per minute. Participants will be given the first flow rate for 30 minutes or until TcO2 reaches a plateau, whichever occurs first. A plateau is defined as when TcO2 increases by no more than 1 kPa over 5 minutes. Nasal high flow will then be stopped and TcO2 will be monitored until TcO2 returns to baseline (+/- 1kPa), whichever occurs first. Then the process will be repeated with the second flow rate. All interventions will be administered by a research doctor and the study will be conducted at an onsite clinic at Fisher & Paykel Healthcare.

Both flow rates will be administered in a crossover fashion to determine intra-participant variability of TcO2 measurements in response to nasal high flow. The total duration of study intervention, which includes both flow rates and washout periods will be no more than 3 hours.
Control group
Active

Outcomes
Primary outcome [1] 332582 0
Absence or presence of a transcutaneous oxygen partial pressure (TcO2) plateau. A transcutaneous oxygen monitor will be used to continuously record in TcO2 measurements for the entire duration of the study.
Timepoint [1] 332582 0
Assessed until TcO2 reaches a plateau for a maximum cut-off of 30 min.

TcO2 will be monitored continuously from the time of commencement of nasal high flow until TcO2 reaches a plateau or up to a maximum of 30 minutes of nasal high flow, whichever occurs first.
Secondary outcome [1] 413967 0
Time to TcO2 plateau (if present) measured by using a transcutaneous oxygen monitor.
Timepoint [1] 413967 0
Assessed when TcO2 reaches a plateau with a maximum cut-off of 30 min. TcO2 will be monitored continuously from commencement of nasal high flow until TcO2 reaches a plateau or up to a maximum of 30 minutes, whichever occurs first.
Secondary outcome [2] 413968 0
Time fromTcO2 plateau (if present) to baseline TcO2 using a transcutaneous oxygen monitor.
Timepoint [2] 413968 0
Assessed when TcO2 returns to baseline with a maximum cut-off of 1 hour. TcO2 will be monitored continuously once nasal high flow is stopped from TcO2 plateau until TcO2 returns to baseline or up to 1 hour after nasal high flow is stopped, whichever occurs first.
Secondary outcome [3] 413970 0
Adverse events and serious adverse events determined by clinical assessment.

Some foreseeable adverse events are nasal/throat pain, atelectasis, skin irritation, nose/throat discomfort. Adverse events will be assessed by participant self-reported or symptom directed physical exam.
Timepoint [3] 413970 0
Monitored from the commencement of study intervention until the end of the second washout period.

Eligibility
Key inclusion criteria
1. Willing and able to provide written informed consent
2. 18 to 40 years of age, inclusive
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Participants where continuous positive airway pressure and nasal high flow are contraindicated (e.g. nasal congestion, currently has or has history of epistaxis, pneumothorax, bullous lung disease, craniofacial trauma, airway foreign body).
2. Known active use of tobacco, vapes, or other inhaled substances.
3. BMI > 35 kg/m2
4. Known fragile skin and/or adhesive allergy
5. Other underlying medical condition that will be unfavourable for the administration of nasal high flow therapy or may impair compliance with study conduct.

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



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Standard descriptive statistics including means, standard deviations, range, frequencies, and percentages will be used to describe the presenting participant demographic features.

The endpoint measure will be summarised as the geometric means of each treament and as geometric mean ratio (70L/min / 10 L/min) of TcO2 plateau.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/11/2022
Actual
29/11/2022
Date of last participant enrolment
Anticipated
8/12/2022
Actual
Date of last data collection
Anticipated
9/12/2022
Actual
Sample size
Target
6
Accrual to date
2
Final
Recruitment outside Australia
Country [1] 25015 0
New Zealand
State/province [1] 25015 0
Auckland

Funding & Sponsors
Funding source category [1] 312268 0
Commercial sector/Industry
Name [1] 312268 0
Fisher & Paykel Healthcare
Country [1] 312268 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare
Address
15 Maurice Paykel Place,
East Tamaki,
Auckland 2013
Country
New Zealand
Secondary sponsor category [1] 313810 0
None
Name [1] 313810 0
Address [1] 313810 0
Country [1] 313810 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311642 0
Health and Disability Ethics Committee
Ethics committee address [1] 311642 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 311642 0
New Zealand
Date submitted for ethics approval [1] 311642 0
03/10/2022
Approval date [1] 311642 0
15/11/2022
Ethics approval number [1] 311642 0

Summary
Brief summary
Transcutaneous oxygen partial pressure (TcO2) is a non-invasive method to measure oxygen partial pressure in participants. TcO2 may also be a useful method to measure the effectiveness of oxygenation in humans, particularly of use in future clinical studies involving healthy volunteers assessing the performance of novel extensions to the NHF system. However, the reliability of TcO2 to measure the effectiveness of oxygenation via NHF has not been previously investigated.
The study is a two arm, randomised controlled, crossover feasibility study to explore transcutaneous oxygen partial pressure (TcO2) as a potential measure for the effectiveness of oxygenation using NHF. Participants will be given NHF at the following flow rates with the standard mechanical flow meter:
- Treatment A: 100% O2 at 10 L/min
- Treatment B: 100% O2 at 70 L/min
Participants will be randomised (1:1) to the sequence of treatment (A-B or B-A). Participants will be instructed to breath normally for the duration of the study, maintaining a respiratory rate of approximately 10-12 breaths per minute. Participants will be given the first flow rate for 30 minutes or until TcO2 reaches a plateau, whichever occurs first. A plateau is defined as when TcO2 increases no more than 1 kPa over 5 minute. Nasal high flow will then be stopped and TcO2 will be monitored for 1 hour or until TcO2 returns to baseline (+/- 1kPa), whichever occurs first. Then the process will be repeated with the second flow rate.
We will include 6 participants randomised at a 1:1 ratio, 3 participants per crossover sequence.
The feasibility endpoints for this study will be: ability to achieve TcO2 plateau, time to TcO2 plateau (if present), time from TcO2 plateau (if present) to baseline, and inter- and intra- participant variability of TcO2. Adverse events will also be collected.
We are conducting this study to confirm whether these endpoints are obtainable and useful for a future non-inferiority study. Data from this study will also be used to calculate the sample size needed for the proposed future study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121822 0
Prof Alan Merry
Address 121822 0
Fisher & Paykel Healthcare
15 Maurice Paykel Place
East Tamaki
Auckland 2013
Country 121822 0
New Zealand
Phone 121822 0
+64 214932297
Fax 121822 0
Email 121822 0
[email protected]
Contact person for public queries
Name 121823 0
Aya Cervantes
Address 121823 0
Fisher & Paykel Healthcare
15 Maurice Paykel Place
East Tamaki
Auckland 2013
Country 121823 0
New Zealand
Phone 121823 0
+64 95740100
Fax 121823 0
Email 121823 0
[email protected]
Contact person for scientific queries
Name 121824 0
Amanda Potts
Address 121824 0
Fisher & Paykel Healthcare
15 Maurice Paykel Place
East Tamaki
Auckland 2013
Country 121824 0
New Zealand
Phone 121824 0
+64 95740100
Fax 121824 0
Email 121824 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
This is an internal feasibility study to aid in product development. Individual participant data will not be shared publicly.


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.