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NCT05059288 Clinical Trial

NIV Mask Assessment of Usability and Performance

Respiratory Failure Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05059288
Other study ID # CIA 291
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 28, 2021
Est. completion date December 31, 2022

Study information
Verified date September 2021
Source Fisher and Paykel Healthcare
Contact Jessica R Fogarin
Phone 095740100
Email jessica.fogarin@fphcare.co.nz
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Investigational Non Invasive Ventilation Mask
Oronasal non invasive ventilation mask

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fisher and Paykel Healthcare

Outcome
Type Measure Description Time frame Safety issue
Primary Perceived mask performance Three point visual analogue scale on preference 1 = Worse, 2 = Same, 3 = Better During the intervention
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