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Vela Generation II: Usability and Performance of a Non-Invasive Ventilation Mask.

NCT07484802 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-20

No results posted yet for this study

Summary

Study Overview The goal of this clinical trial is to learn whether an improved non invasive ventilation mask with airway washout can reduce how often people need to breathe and perform as well as standard NIV masks when used with different ventilators, in people receiving NIV therapy for respiratory distress or respiratory insufficiency.

The main question(s) it aims to answer are:

* Does the new mask reduce breathing rate compared with a standard NIV mask?
* Does the ventilator perform as expected when used with the new mask, including pressure delivery and leak?
* Do clinicians and participants find the new mask fits and functions well?

Three iterations of the new mask (vented, non-vented, dual limb) will be compared to standard of care to see if the mask reduces the need to breathe and performs consistently across ventilators compared with usual NIV masks.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ What Participants Will Do Participants will wear two different NIV masks, each for one hour, during a single study session lasting approximately 2.5 hours.

Participants will be asked to:

* Wear a small, stick on carbon dioxide (CO₂) sensor on the skin.
* Use their usual NIV mask for one hour while ventilator data are collected.
* Switch to the investigational mask for one hour while ventilator data are collected.
* Choose whether to return to their original mask or remain on the investigational mask after the study period.
* Caregiver opinion on the mask will be collected.

Participants may also choose (optional):

* To have three small blood samples taken (These samples are optional, and participants can still take part in the study if they decline them.)

* One when they agree to take part in the study
* One when the investigational mask is fitted
* One after wearing the investigational mask for one hour
* To provide feedback on how the two masks felt and performed.

During the study, researchers will collect data from the ventilator, including:

* Breathing rate and depth
* NIV pressure settings
* Amount of air leak Research staff will also complete a short form assessing how well the mask fit and functioned. Participants will remain in the study until the investigational mask is removed.

Conditions

Interventions

OTHER

NIV interface with airway washout

This is a new design of the OptiNIV mask with airway washout that is commercially available.

Sponsors & Collaborators

  • Middlemore Hospital, New Zealand

    collaborator OTHER

  • Fisher and Paykel Healthcare

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-12-31
Completion
2027-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07484802 on ClinicalTrials.gov