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NOT YET RECRUITING
NCT06939920
NA

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

Sponsor: Fisher and Paykel Healthcare

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-07-01

Completion Date

2026-07-01

Last Updated

2025-05-22

Healthy Volunteers

No

Interventions

OTHER

Non-invasive ventilation mask with airway washout

Non-invasive ventilation mask with airway washout for dual limb ventilators

OTHER

non-invasive ventilation

standard state of the art non-invasive ventilation