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

NCT06670482 | Completed

• 2 other identifiers: CIA-351U1111-1313-6217
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers; Noninvasive Ventilation

Keywords

Non-invasive ventilation; mask; Transcutaneous CO2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in respiratory rate

  Continuous assessment collected during baseline normal breathing and from the start to the finish of each NIV session.

• Change in tidal volume

  Continuous assessment collected during baseline normal breathing and from the start to the finish of each NIV session.

Study Arms (4)

Arm 1

EXPERIMENTAL

NIV using Mask A, with mouth-open

Device: Non-invasive ventilation (NIV)

Arm 2

EXPERIMENTAL

NIV using Mask A, with mouth-closed

Device: Non-invasive ventilation (NIV)

Arm 3

ACTIVE COMPARATOR

NIV using Mask B, with mouth-open

Device: Non-invasive ventilation (NIV)

Arm 4

ACTIVE COMPARATOR

NIV using Mask B, with mouth-closed

Device: Non-invasive ventilation (NIV)

Interventions

Non-invasive ventilation (NIV) DEVICE

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

Arm 1; Arm 2; Arm 3; Arm 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or over
• Able to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (1)

Fisher and Paykel Healthcare

Auckland, Auckland, 2013, New Zealand

Location

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• William Good, MD

  Middlemore Hospital, New Zealand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, cross-over, non-blinded

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 1, 2024
• Study Start: November 18, 2024
• Primary Completion: February 14, 2025
• Study Completion: February 14, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)