NIV Mask Assessment of Usability and Performance

Not Applicable

• Conditions: Respiratory Failure
• Interventions: Device: Investigational Non Invasive Ventilation Mask

• 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.

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-06
• Study First Submitted QC: 2021-09-19
• Last Update Submitted: 2021-09-19
• Study First Posted: 2021-09-28
• Last Update Posted: 2021-09-28
• Study Start: 2021-10-28
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

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

Arm && Interventions

Group	Intervention	Description
Investigation Mask	Investigational Non Invasive Ventilation Mask	Non invasive ventilation mask

Primary Outcome Measures

Name	Time	Method
Perceived mask performance	During the intervention	Three point visual analogue scale on preference 1 = Worse, 2 = Same, 3 = Better