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

Fisher & Paykel Healthcare

Status: Completed

Conditions: Healthy Volunteers; Noninvasive Ventilation

Treatments: Device: Non-invasive ventilation (NIV)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06670482

U1111-1313-6217 (Other Identifier)

CIA-351

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 4 patient groups

Arm 1

Experimental group

Description:

NIV using Mask A, with mouth-open

Treatment:

Device: Non-invasive ventilation (NIV)

Arm 2

Experimental group

Description:

NIV using Mask A, with mouth-closed

Treatment:

Device: Non-invasive ventilation (NIV)

Arm 3

Active Comparator group

Description:

NIV using Mask B, with mouth-open

Treatment:

Device: Non-invasive ventilation (NIV)

Arm 4

Active Comparator group

Description:

NIV using Mask B, with mouth-closed

Treatment:

Device: Non-invasive ventilation (NIV)