The Effect of Mask Design on Transcutaneous Carbon Dioxid... | NCT06670482

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

NCT06670482

Sponsor

Fisher and Paykel Healthcare

Status

Completed

Last Update Posted

Apr 24, 2025Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Healthy Volunteers
Noninvasive Ventilation

Interventions

Non-invasive ventilation (NIV)

Countries

New Zealand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1313-6217	Other Identifier	World Health Organisation

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 18, 2024Actual

Primary Completion Date

Feb 14, 2025Actual

Completion Date

Feb 14, 2025Actual

First Submitted Date

Oct 31, 2024

First Submission Date that Met QC Criteria

Oct 31, 2024

First Posted Date

Nov 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2025

Last Update Posted Date

Apr 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William Good, MD	Middlemore Hospital, New Zealand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fisher and Paykel Healthcare		Auckland	Auckland	2013	New Zealand

IPD Sharing Statement Module

Plan to Share IPD

Description

All data to be deidentified.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D063087	Noninvasive Ventilation

Ancestor Terms

ID	Term
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics
D012138	Respiratory Therapy

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Browse Branches

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