Healthy VolunteersNCT06670482
The Effect of Mask Design on Transcutaneous Carbon Dioxide in Healthy Volunteers: A Pilot Clinical Investigation
A study testing Non-invasive ventilation (NIV) in people with Healthy Volunteers and Noninvasive Ventilation, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
Trial summary
The goal of this randomized cross-over study is to investigate whether the design of non-invasive ventilation (NIV) mask impacts transcutaneous CO2 in healthy volunteers on NIV therapy. The main questions it aims to answer are: To assess if mask design impacts transcutaneous CO2 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Noninvasive Ventilation
- What is being tested?
- Non-invasive ventilation (NIV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNew Zealand
- Study dates
- 18 Nov 2024to 14 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or over
- Able to give informed consent
Who cannot join
- Unable to tolerate non-invasive ventilation (NIV)
- Unable to adequately fit an NIV mask
- Claustrophobia while using NIV
- Reported pregnancy
- Symptoms of cold or flu (included COVID-19) in previous twenty four hours
- Pneumothorax or history of previous pneumothorax
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this randomized cross-over study is to investigate whether the design of non-invasive ventilation (NIV) mask impacts transcutaneous CO2 in healthy volunteers on NIV therapy. The main questions it aims to answer are:
- To assess if mask design impacts transcutaneous CO2 in healthy volunteers.
- To assess if mask design impacts tidal volume or respiratory rate in healthy volunteers.
Read more
Participants will attend three study visits:
- Visit 1. Participants will be fitted to use non-invasive ventilation briefly to acclimatize them to using the therapy.
- Visit 2. Participants will receive NIV with one of two masks. They will be asked to breathe through their mouth or through their nose, with a break from NIV in between the two sessions of NIV.
- Visit 3. Participants will receive NIV with the other mask, repeating Visit 2.
Read the detailed description
The study compares breathing with two different NIV masks, the interventional mask and the conventional NIV mask. Participants will be monitored by transcutaneous carbon dioxide, electrical impedance tomography (EIT) and heart rate, oxygen and respiratory rate monitors.
Participants will attend three study visits:
- Visit 1. Participants will be fitted to use NIV briefly to acclimatize them to using the therapy and ensure the two study masks fit. Participants that fit the masks and tolerate NIV well will be invited to attend two further visits.
- Visit 2. Participants will be randomized as to which order they receive the masks and which order they conduct mouth breathing and nose breathing. Baseline readings of normal unsupported breathing will be taken prior to going on NIV. Participants will the receive NIV with one of two masks for ten minutes, and will be instructed to either breathe with their mouth open or their mouth closed. There will then be a break from NIV of at least ten minutes until baseline values of respiratory parameters have returned. Then there will be a second ten minute period of NIV when the participant will be instructed to breathe through the other way - mouth-closed or mouth-open. One NIV therapy has been removed the participant will remain attached to the study monitoring equipment until respiratory parameters have returned to normal.
- Visit 3 is a repeat of Visit 2 with the other study mask. The study is then complete.
- Conditions
- Healthy Volunteers, Noninvasive Ventilation
- Being tested
- Non-invasive ventilation (NIV)
- Keywords
- Non-invasive ventilation, mask, Transcutaneous CO2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive ventilation (NIV)Device
Delivery of positive airway pressure to the lungs via an interface, such as a mask.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | NIV using Mask A, with mouth-open Receives: Device: Non-invasive ventilation (NIV) |
| Arm 2 | Experimental | NIV using Mask A, with mouth-closed Receives: Device: Non-invasive ventilation (NIV) |
| Arm 3 | Active comparator | NIV using Mask B, with mouth-open Receives: Device: Non-invasive ventilation (NIV) |
| Arm 4 | Active comparator | NIV using Mask B, with mouth-closed Receives: Device: Non-invasive ventilation (NIV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in transcutaneous carbon dioxide (CO2)
To assess if mask design can reduce transcutaneous CO2, in healthy volunteers.
Measured: Continuous assessment collected during baseline normal breathing and from the start to the finish of each NIV session.
Secondary outcomes (2)
Change in respiratory rate
To assess if mask design can reduce respiratory rate in healthy volunteers.
Measured: Continuous assessment collected during baseline normal breathing and from the start to the finish of each NIV session.
Change in tidal volume
To assess if mask design can reduce tidal volume in healthy volunteers.
Measured: Continuous assessment collected during baseline normal breathing and from the start to the finish of each NIV session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start18 Nov 2024
- Primary completion14 Feb 2025
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Fisher and Paykel HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, cross-over, non-blinded
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Good, MD, Principal investigator, Middlemore Hospital, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670482
- Sponsor's protocol ID
- CIA-351
- Other IDs
- U1111-1313-6217
- Status last verified
- Apr 2025
- First submitted
- 31 Oct 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data to be deidentified.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mask Design on Transcutaneous Carbon Dioxide in Healthy Volunteers: A Pilot Clinical Investigation
- ClinicalTrials.gov ID
- NCT06670482
- Acronym / sponsor ID
- CIA-351
- Conditions
- Healthy Volunteers, Noninvasive Ventilation
- Keywords
- Non-invasive ventilation, mask, Transcutaneous CO2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized cross-over study is to investigate whether the design of non-invasive ventilation (NIV) mask impacts transcutaneous CO2 in healthy volunteers on NIV therapy. The main questions it aims to answer are:
- To assess if mask design impacts transcutaneous CO2 in healthy volunteers.
- To assess if mask design impacts tidal volume or respiratory rate in healthy volunteers.
Participants will attend three study visits:
- Visit 1. Participants will be fitted to use non-invasive ventilation briefly to acclimatize them to using the therapy.
- Visit 2. Participants will receive NIV with one of two masks. They will be asked to breathe through their mouth or through their nose, with a break from NIV in between the two sessions of NIV.
- Visit 3. Participants will receive NIV with the other mask, repeating Visit 2.
Detailed description
The study compares breathing with two different NIV masks, the interventional mask and the conventional NIV mask. Participants will be monitored by transcutaneous carbon dioxide, electrical impedance tomography (EIT) and heart rate, oxygen and respiratory rate monitors.
Participants will attend three study visits:
- Visit 1. Participants will be fitted to use NIV briefly to acclimatize them to using the therapy and ensure the two study masks fit. Participants that fit the masks and tolerate NIV well will be invited to attend two further visits.
- Visit 2. Participants will be randomized as to which order they receive the masks and which order they conduct mouth breathing and nose breathing. Baseline readings of normal unsupported breathing will be taken prior to going on NIV. Participants will the receive NIV with one of two masks for ten minutes, and will be instructed to either breathe with their mouth open or their mouth closed. There will then be a break from NIV of at least ten minutes until baseline values of respiratory parameters have returned. Then there will be a second ten minute period of NIV when the participant will be instructed to breathe through the other way - mouth-closed or mouth-open. One NIV therapy has been removed the participant will remain attached to the study monitoring equipment until respiratory parameters have returned to normal.
- Visit 3 is a repeat of Visit 2 with the other study mask. The study is then complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized, cross-over, non-blinded
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: Non-invasive ventilation (NIV)NIV using Mask A, with mouth-open |
| Arm 2 | Experimental | Device: Non-invasive ventilation (NIV)NIV using Mask A, with mouth-closed |
| Arm 3 | Active comparator | Device: Non-invasive ventilation (NIV)NIV using Mask B, with mouth-open |
| Arm 4 | Active comparator | Device: Non-invasive ventilation (NIV)NIV using Mask B, with mouth-closed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 years or over
- Able to give informed consent
Key exclusion criteria (6 listed)
- Unable to tolerate non-invasive ventilation (NIV)
- Unable to adequately fit an NIV mask
- Claustrophobia while using NIV
- Reported pregnancy
- Symptoms of cold or flu (included COVID-19) in previous twenty four hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive ventilation (NIV)Delivery of positive airway pressure to the lungs via an interface, such as a mask. | Device | Arm 1, Arm 2, Arm 3, Arm 4 |
Primary outcome
Change in transcutaneous carbon dioxide (CO2)
Time frame: Continuous assessment collected during baseline normal breathing and from the start to the finish of each NIV session.
To assess if mask design can reduce transcutaneous CO2, in healthy volunteers.
2 secondary outcomes
Change in respiratory rate
Time frame: Continuous assessment collected during baseline normal breathing and from the start to the finish of each NIV session.
Change in tidal volume
Time frame: Continuous assessment collected during baseline normal breathing and from the start to the finish of each NIV session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No. All data to be deidentified.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Good, MD principal investigator
Middlemore Hospital, New Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive ventilation (NIV) in people with Healthy Volunteers and Noninvasive Ventilation, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in transcutaneous carbon dioxide (CO2) (time frame: Continuous assessment collected during baseline normal breathing and from the start to the finish of each NIV session.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.