Clinical Trial

Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.

Recruiting
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Record status
This record was last updated March 14, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-08-21; most recent amendment 2025-03-12.
Status change: Not Yet Recruiting → Recruiting 2024-09-22
Trial Details
NCT Number NCT06007495
Lead Sponsor Fisher and Paykel Healthcare
Collaborators: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Centre hospitalier de l'Université de Montréal (CHUM)
Conditions Acute Hypercapnic Respiratory Failure, Acute Hypoxemic Respiratory Failure
Enrollment 32 participants
Start Date 2024-05-06
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-03-14