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Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.
Sponsor: Fisher and Paykel Healthcare
Summary
The goal of this pilot randomized cross-over study is to compare the effect of a full-face mask with expiratory washout to a conventional full face mask on non-invasive ventilation (NIV) in patients with acute hypercapnic, and acute hypoxemic, respiratory failure. The main questions it aims to answer are: * Does a mask with expiratory washout improve minute ventilation in patients using non-invasive ventilation compared with a conventional single-limb NIV mask * How does a mask with expiratory washout affect respiratory variables compared with a dual-limb NIV mask. Participants already prescribed NIV will undergo 3 arms of the investigation in a randomized order: * Single-limb NIV with investigation mask (with expiratory washout) * Single-limb NIV with conventional mask * Dual-limb NIV with conventional mask
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2024-05-06
Completion Date
2025-12
Last Updated
2025-03-14
Healthy Volunteers
No
Interventions
Investigational full-face mask with expiratory washout
With cross-over in randomized order, mask worn for 30 minutes with prescribed single-limb non-invasive ventilation
Conventional full-face mask - single-limb
With cross-over in randomized order, conventional mask such as RT077, worn for 30 minutes with prescribed single-limb non-invasive ventilation
Conventional full-face mask - dual-limb
With cross-over in randomized order, conventional mask such as RT076, worn for 30 minutes with prescribed dual-limb non-invasive ventilation
Locations (2)
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Québec, Quebec, Canada