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The Effect of Mask Design on Transcutaneous Carbon Dioxide in Healthy Volunteers: A Pilot Clinical Investigation

NCT06670482 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-04-24

No results posted yet for this study

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.
* 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.

Conditions

  • Healthy Volunteers
  • Noninvasive Ventilation

Interventions

DEVICE

Non-invasive ventilation (NIV)

Delivery of positive airway pressure to the lungs via an interface, such as a mask.

Sponsors & Collaborators

  • Fisher and Paykel Healthcare

    lead INDUSTRY

Principal Investigators

  • William Good, MD · Middlemore Hospital, New Zealand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-18
Primary Completion
2025-02-14
Completion
2025-02-14

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06670482 on ClinicalTrials.gov