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Completed

NCT Number: NCT06670482

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

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.

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Key information

Conditions

Healthy Volunteers Noninvasive Ventilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fisher and Paykel Healthcare

Auckland, 2013, New Zealand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or over
  • Able to give informed consent

Exclusion criteria

  • 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

Treatment and study plan

Non-invasive ventilation (NIV)

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in respiratory rate

    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 respiratory rate in healthy volunteers.

  2. Change in tidal volume

    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 tidal volume in healthy volunteers.

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 1, 2024
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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