ANZCTR - Registration

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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anaesthesia

Condition category

Condition code

Anaesthesiology

Other anaesthesiology

Respiratory

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]

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]

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]

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]

Time to TcO2 plateau (if present) measured by using a transcutaneous oxygen monitor.

Timepoint [1]

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]

Time fromTcO2 plateau (if present) to baseline TcO2 using a transcutaneous oxygen monitor.

Timepoint [2]

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]

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]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Fisher & Paykel Healthcare

Address [1]

15 Maurice Paykel Place,
East Tamaki,
Auckland 2013

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

03/10/2022

Approval date [1]

15/11/2022

Ethics approval number [1]

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

Prof Alan Merry

Address

Fisher & Paykel Healthcare
15 Maurice Paykel Place
East Tamaki
Auckland 2013

Country

New Zealand

Phone

+64 214932297

Fax

a.merry@auckland.ac.nz

Contact person for public queries

Name

Aya Cervantes

Address

Fisher & Paykel Healthcare
15 Maurice Paykel Place
East Tamaki
Auckland 2013

Country

New Zealand

Phone

+64 95740100

Fax

aya.cervantes@fphcare.co.nz

Contact person for scientific queries

Name

Amanda Potts

Address

Fisher & Paykel Healthcare
15 Maurice Paykel Place
East Tamaki
Auckland 2013

Country

New Zealand

Phone

+64 95740100

Fax

amanda.potts@fphcare.co.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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