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NCT06670482
The Effect of Mask Design on Transcutaneous Carbon Dioxide in Healthy Volunteers: A Pilot Clinical Investigation
NA trial testing Non-invasive ventilation (NIV) in Healthy Volunteers in 10 participants. Completed in 14 February 2025.
14 February 2025
Quick facts
| Lead sponsor | Fisher and Paykel Healthcare |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 18 November 2024 |
| Primary completion | 14 February 2025 |
| Estimated completion | 14 February 2025 |
| Sites | 1 location across New Zealand |
Drugs / interventions tested
- Non-invasive ventilation (NIV)
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
- Noninvasive Ventilation — all drugs for Noninvasive Ventilation →
Sponsor
Fisher and Paykel Healthcare — full company profile →
Who can join
18 and older, any sex, with Healthy Volunteers or Noninvasive Ventilation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06670482
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Non-invasive ventilation (NIV)
Trials testing the same drug.
- NCT05012696 — Physiological Effects of Non-invasive Mechanical Ventilation Versus High-flow Nasal Cannula in Critically Ill Patients a · NA · completed
Other recruiting trials for Healthy Volunteers
Currently open trials in the same condition.
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- NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
- NCT07495813 — A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease · Phase 1 · recruiting
- NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
- NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting
Other Fisher and Paykel Healthcare trials
Trials by the same sponsor.
- NCT07484802 — Vela Generation II: Usability and Performance of a Non-Invasive Ventilation Mask. · NA · not yet recruiting
- NCT06939920 — NIV With Airway Washout for Dual Limb Ventilation: Improvement in Minute Ventilation · NA · not yet recruiting
- NCT06738589 — The Inflate Study; Defining the Soft Palate in the Upper Airway Flow Pathway · NA · not yet recruiting
- NCT06060717 — Evaluation of the F&P Caramel Nasal Mask, US, 2023 · NA · completed
- NCT05422248 — Oxygen Wound Therapy Feasibility Study · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06670482 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fisher and Paykel Healthcare
- Last refreshed: 24 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06670482.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing