MedPath

NIV Mask Assessment of Usability and Performance

Not Applicable
Conditions
Respiratory Failure
Registration Number
NCT05059288
Lead Sponsor
Fisher and Paykel Healthcare
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
50
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

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Perceived mask performanceDuring the intervention

Three point visual analogue scale on preference 1 = Worse, 2 = Same, 3 = Better

Secondary Outcome Measures
NameTimeMethod

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