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Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.

StatusUnknown
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Primary and study completion dates: Feb 2025 to Dec 2025v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2023 to May 6, 2024
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
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
(from sponsor)		 Acute Hypercapnic Respiratory Failure, Acute Hypoxemic Respiratory Failure
Related terms Respiratory Insufficiency
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov