Back to resultsNIV Mask Assessment of Usability and Performance
Primary Purpose
Respiratory Failure
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Investigational Non Invasive Ventilation Mask
Sponsored by
About this trial
This is an interventional other trial for Respiratory Failure
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Investigation Mask
Arm Description
Non invasive ventilation mask
Outcomes
Primary Outcome Measures
Perceived mask performance
Three point visual analogue scale on preference 1 = Worse, 2 = Same, 3 = Better
Secondary Outcome Measures
Full Information
NCT ID
NCT05059288
First Posted
September 6, 2021
Last Updated
September 19, 2021
Sponsor
Fisher and Paykel Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT05059288
Brief Title
NIV Mask Assessment of Usability and Performance
Official Title
Usability and Performance of a Non-invasive Ventilation Mask. A Prospective Cohort.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 28, 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Investigation Mask
Arm Type
Experimental
Arm Description
Non invasive ventilation mask
Intervention Type
Device
Intervention Name(s)
Investigational Non Invasive Ventilation Mask
Intervention Description
Oronasal non invasive ventilation mask
Primary Outcome Measure Information:
Title
Perceived mask performance
Description
Three point visual analogue scale on preference 1 = Worse, 2 = Same, 3 = Better
Time Frame
During the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica R Fogarin
Phone
095740100
Email
jessica.fogarin@fphcare.co.nz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Martynoga
Organizational Affiliation
Waikato Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
NIV Mask Assessment of Usability and Performance
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