NIV Mask Assessment of Usability and Performance

Fisher & Paykel Healthcare

Status: Unknown

Conditions: Respiratory Failure

Treatments: Device: Investigational Non Invasive Ventilation Mask

Study type: Interventional

Funder types: Industry

Identifiers

NCT05059288

CIA 291

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Investigation Mask

Experimental group

Description:

Non invasive ventilation mask

Treatment:

Device: Investigational Non Invasive Ventilation Mask