FindTrial
Sign In

NIV Mask Assessment of Usability and Performance

Usability and Performance of a Non-invasive Ventilation Mask. A Prospective Cohort.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05059288
Enrollment
50
Registered
2021-09-28
Start date
2021-10-28
Completion date
2022-12-31
Last updated
2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

Brief summary

Assessment of usability, perceived comfort and performance of a NIV mask in the hospital environment.

Detailed description

50 participants admitted for NIV therapy will have the investigation mask fitted. The doctors and nurses assigned to the participants care will complete a subjective evaluation on how the mask performs compared to the standard of care mask. Some therapy settings and demographics will be recorded.

Interventions

DEVICEInvestigational Non Invasive Ventilation Mask

Oronasal non invasive ventilation mask

Sponsors

Fisher and Paykel Healthcare
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Admitted and indicated for non invasive ventilation therapy * Assessed for capacity to consent and consent process documented * Fits the investigation mask * Aged 18 year or older

Exclusion criteria

\- Contraindicated for non invasive ventilation

Design outcomes

Primary

MeasureTime frameDescription
Perceived mask performanceDuring the interventionThree point visual analogue scale on preference 1 = Worse, 2 = Same, 3 = Better

Contacts

Primary ContactJessica R Fogarin
jessica.fogarin@fphcare.co.nz095740100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026