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

NCT07484802 | Not Yet Recruiting

• 1 other identifier: CIA-379
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Respiratory Insufficiency; Respiratory Failure

Keywords

Airway washout; Fisher and Paykel healthcare; optiNIV; vela gen 2

Outcome Measures

Primary Outcomes (1)

• respiratory rate

  A reduction in respiratory rate of 3 bpm. The RR will be taken off the ventilator as a continuous measure out of the coms protocol we will download. Point measures will also be taken in the event the vent data is corrupted. RR at 10 min intervals will be noted down in the CRF. We expect a normal improvement in ventilation over time but are expecting a steeper improvement in RR in the intervention arm of 3 BPM.

  1 hour per arm of continuous ventilator data.

Other Outcomes (2)

• caregiver evaluation

  The CRF will be completed at the end of the intervention period (1 hour) and once the interventional mask is removed if this is at a later timepoint.

• vT

  1 hour

Study Arms (2)

Investigational Mask

EXPERIMENTAL

This is the arm with the second generation OptiNIV mask with airway washout. this new mask function very much like the commercially available OptiNIV mask but for a wider population as the maximum pressure is 40 not 30 cmH20 and on a wider variety of ventilators now also having a dual limb solution.

Other: NIV interface with airway washout

Standard care

NO INTERVENTION

The standard of care mask the participant is on when they are recruited. this is the comparator.

Interventions

NIV interface with airway washout OTHER

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

Investigational Mask

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults that are stable on prescribed NIV
• Able to receive NIV therapy on a sub-nasal mask
• Are 21 years old or older

You may not qualify if:

• Contraindicated for NIV
• NIV is likely to fail and/or intubation be required, at the doctor's discretion
• CPAP or bilevel pressure of ≥ 30 cmH2O required
• Do not fit the investigation mask or the standard mask
• Pregnancy (tested under standard care)
• Unable to tolerate NIV for the duration of the investigation
• Unable to understand the consent process

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead
• Middlemore Hospital, New Zealand: collaborator

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Senior clinical research scientist, doctorate

CONTACT

+64210624848; lotte.vandenheuij@fphcare.co.nz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: due to the nature of the study it is not possible to blind the investigator or the participant to the mask type, they look different. The objective ventilatory parameters will be assessed blindly.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, non-randomized self controlled study. Comparing within participant outcomes between standard of care and the novel mask with airway washout

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 20, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share