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

NCT ID: NCT06670482

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-18
• Study Completion Date: 2025-02-14

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1

NIV using Mask A, with mouth-open

Group Type: EXPERIMENTAL

Non-invasive ventilation (NIV)

Intervention Type: DEVICE

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

Arm 2

NIV using Mask A, with mouth-closed

Group Type: EXPERIMENTAL

Non-invasive ventilation (NIV)

Intervention Type: DEVICE

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

Arm 3

NIV using Mask B, with mouth-open

Group Type: ACTIVE_COMPARATOR

Non-invasive ventilation (NIV)

Intervention Type: DEVICE

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

Arm 4

NIV using Mask B, with mouth-closed

Group Type: ACTIVE_COMPARATOR

Non-invasive ventilation (NIV)

Intervention Type: DEVICE

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

Interventions

Non-invasive ventilation (NIV)

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Good, MD

Role: PRINCIPAL_INVESTIGATOR

Middlemore Hospital, New Zealand

Locations

Fisher and Paykel Healthcare

Auckland, Auckland, New Zealand

Countries

New Zealand

Other Identifiers

U1111-1313-6217

Identifier Type: OTHER

Identifier Source: secondary_id

CIA-351

Identifier Type: -

Identifier Source: org_study_id