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NIV With Airway Washout for Dual Limb Ventilation: Improvement in Minute Ventilation

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated May 22, 2025 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Enrollment target: 40 to 20v2 Show 6 more changesShow less
    • Start date: May 1, 2025 to Jul 1, 2025
    • Primary endpoint revised
    • Primary and study completion dates: May 1, 2026 to Jul 1, 2026
    • Secondary endpoints: 4 to 5
    • Study description expanded, about 135 words
    • Study title expanded, about 1 word
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a prospective, non-randomized, non-blinded, crossover feasibility investigation to assess the safety, usability, and efficacy of the investigational mask in the hospital environment. Eligible patients that are stable in NIV and able to give informed consent will be approached and if they consent the patient will be included in the study. If potential participants decline, normal hospital care will be continued. The enrolled participant will receive NIV on the commercially available Visairo mask for one hour during which their ventilatory parameters will be logged. Then the participant will be switched to the investigational mask for another hour. The ventilator data will be collected for these two hours. At the end of the intervention the participant will be reverted to their original mask. The medical staff will be asked to fill out the case report form pertaining to the function and usability of the investigational mask compared to the conventional mask.
Trial Details
NCT Number NCT06939920
Lead Sponsor Fisher and Paykel Healthcare
Conditions
(from sponsor)		 Respiratory Failure Requiring Non Invasive Ventilation
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov