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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Noninvasive Ventilation
• Intervention / Treatment: Device: Non-invasive ventilation (NIV)

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand, 2013
    • Fisher and Paykel Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; NIV using Mask A, with mouth-open	Device: Non-invasive ventilation (NIV); Delivery of positive airway pressure to the lungs via an interface, such as a mask.
Experimental: Arm 2; NIV using Mask A, with mouth-closed	Device: Non-invasive ventilation (NIV); Delivery of positive airway pressure to the lungs via an interface, such as a mask.
Active Comparator: Arm 3; NIV using Mask B, with mouth-open	Device: Non-invasive ventilation (NIV); Delivery of positive airway pressure to the lungs via an interface, such as a mask.
Active Comparator: Arm 4; NIV using Mask B, with mouth-closed	Device: Non-invasive ventilation (NIV); Delivery of positive airway pressure to the lungs via an interface, such as a mask.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in transcutaneous carbon dioxide (CO2)	To assess if mask design can reduce transcutaneous CO2, in healthy volunteers.	Continuous assessment collected during baseline normal breathing and from the start to the finish of each NIV session.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in respiratory rate	To assess if mask design can reduce respiratory rate in healthy volunteers.	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.	Continuous assessment collected during baseline normal breathing and from the start to the finish of each NIV session.

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: William Good, MD, Middlemore Hospital, New Zealand

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Actual): February 14, 2025
• Study Completion (Actual): February 14, 2025

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Non-invasive ventilation; mask; Transcutaneous CO2
• Other Study ID Numbers: CIA-351; U1111-1313-6217 (Other Identifier: World Health Organisation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data to be deidentified.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No