NCT06670482

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Non-invasive ventilation (NIV)	Delivery of positive airway pressure to the lungs via an interface, such as a mask.

Timeline

• Start date: 2024-11-18
• Primary completion: 2025-02-14
• Completion: 2025-02-14
• First posted: 2024-11-01
• Last updated: 2025-04-24

Locations

1 site across 1 country: New Zealand