NIV Mask Assessment of Usability and Performance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-28

Study Completion Date

2022-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Respiratory Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Investigation Mask

Non invasive ventilation mask

Group Type EXPERIMENTAL

Investigational Non Invasive Ventilation Mask

Intervention Type DEVICE

Oronasal non invasive ventilation mask

Interventions

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Investigational Non Invasive Ventilation Mask

Oronasal non invasive ventilation mask

Intervention Type DEVICE

Eligibility Criteria

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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