None listed
Conditions
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.
Interventions
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
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.
Sponsors
Fisher & Paykel Healthcare
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Willing and able to provide written informed consent 2. 18 to 40 years of age, inclusive
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.
Outcome results
None listed