Actively Recruiting
Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.
Led by Fisher and Paykel Healthcare · Updated on 2025-03-14
32
Participants Needed
2
Research Sites
82 weeks
Total Duration
On this page
Sponsors
F
Fisher and Paykel Healthcare
Lead Sponsor
I
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- No indication of intubation within the next 2 hours as evaluated by a physician
- Ability to fit the investigational full-face mask
- For hypercapnic patients: hospitalized with acute respiratory failure stabilized and tolerating NIV, or admitted with acute respiratory failure meeting NIV criteria such as hypercapnia with acidosis or post-extubation risk within 48 hours
- For hypoxemic patients: hypoxemic respiratory failure without hypercapnia requiring nasal high flow or NIV, or requiring conventional oxygen therapy over 6 L/min with oxygen saturation below 92%
You will not qualify if you...
- Refusal to participate in the study
- Inability to provide informed consent
- Infectious isolation status
- Facial deformity, burns, or morphology preventing proper mask placement
- Claustrophobia
- Nausea
- Presence of nasogastric tube
- Pneumothorax
- Confusion or loss of consciousness
- Severe upper gastrointestinal bleeding
- Any condition that investigators believe may pose a safety risk or affect study feasibility or results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, 20094
Actively Recruiting
2
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Québec, Quebec, Canada, 2712
Actively Recruiting
Research Team
J
James Miller
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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