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

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.

NCT Number	NCT06939920
Lead Sponsor	Fisher and Paykel Healthcare
Conditions	Respiratory Failure Requiring Non Invasive Ventilation
Enrollment	20 participants
Start Date	2025-07-01
Primary Completion	2026-07-01 (estimated)
Study Completion	2026-07-01 (estimated)
Updated on ClinicalTrials.gov	2025-05-22