The Effect of Home and Hospital Mask Designs on Respiratory Variables in Healthy Volunteers

The Effect of Home and Hospital Mask Designs on Respiratory Variables 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 respiratory variables in healthy volunteers on NIV therapy. The main questions it aims to answer are:

• To assess if mask design impacts the ventilatory ratio in healthy volunteers.
• To assess if mask design impacts transcutaneous CO2, respiratory rate, and tidal volume in healthy volunteers.

Participants will attend five 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 four 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.
• Visits 3-5. Participants will receive NIV with one of the other three masks, repeating Visit 2.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: Non-invasive ventilation (NIV)

Detailed Description

The study compares breathing with four different NIV masks, the interventional mask and three conventional NIV masks. Participants will be monitored by transcutaneous carbon dioxide, heart rate, oxygen, and respiratory rate monitors.

Participants will attend five study visits:

• Visit 1. Participants will be fitted to use NIV briefly to acclimatize them to using the therapy and ensure the four study masks fit. Participants that fit the masks and tolerate NIV well will be invited to attend four 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 four masks for ten minutes and will be instructed to either breathe through their mouth or their nose. 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 through the nose or mouth. Once NIV therapy has been removed the participant will remain attached to the study monitoring equipment until respiratory parameters have returned to normal.
• Visits 3-5 are a repeat of Visit 2 with the other study masks. The study is then complete.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivia Kennington; Phone Number: 5425 +64(09)5740100; Email: olivia.kennington@fphcare.co.nz

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
• Symptoms of cold or flu (including COVID-19) in previous twenty-four hours
• Chronic Rhinitis or self-reported history of upper airway obstruction
• Pneumothorax or history of previous pneumothorax
• Employee in the NIV team at Fisher & Paykel Healthcare

Study Plan

How is the study designed?

Design Details

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

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NIV using Mask A, with mouth-open; Mask A is the investigational mask	Device: Non-invasive ventilation (NIV); Delivery of positive airway pressure to the lungs via an interface, such as a mask
Experimental: NIV using Mask A, with mouth-closed; Mask A is the investigational mask	Device: Non-invasive ventilation (NIV); Delivery of positive airway pressure to the lungs via an interface, such as a mask
Active Comparator: NIV using Mask B, with mouth-open; Mask B is a comparator mask	Device: Non-invasive ventilation (NIV); Delivery of positive airway pressure to the lungs via an interface, such as a mask
Active Comparator: NIV using Mask B, with mouth-closed; Mask B is a comparator mask	Device: Non-invasive ventilation (NIV); Delivery of positive airway pressure to the lungs via an interface, such as a mask
Active Comparator: NIV using Mask C, with mouth-open; Mask C is a comparator mask	Device: Non-invasive ventilation (NIV); Delivery of positive airway pressure to the lungs via an interface, such as a mask
Active Comparator: NIV using Mask C, with mouth-closed; Mask C is a comparator mask	Device: Non-invasive ventilation (NIV); Delivery of positive airway pressure to the lungs via an interface, such as a mask
Active Comparator: NIV using Mask D, with mouth-open; Mask D is a comparator mask	Device: Non-invasive ventilation (NIV); Delivery of positive airway pressure to the lungs via an interface, such as a mask
Active Comparator: NIV using Mask D, with mouth-closed; Mask D is a comparator mask	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 ventilatory ratio	To assess if mask design can reduce ventilatory ration in healthy volunteers	15 minutes

Secondary 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	15 minutes
Change in respiratory rate	To assess if mask design can reduce respiratory rate in healthy volunteers	15 minutes
Change in tidal volume	To assess if mask design can reduce tidal volume in healthy volunteers	15 minutes

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pulmonary; Noninvasive ventilation
• Additional Relevant MeSH Terms: Therapeutics; Airway Management; Respiratory Therapy; Respiration, Artificial; Noninvasive Ventilation
• Other Study ID Numbers: CIA-366; U1111-1321-2331 (Other Identifier: WHO)

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