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Clinical Trial Summary

This study will determine if NIV using the Vela investigational mask with expiratory washout of the upper airway more effectively reduces respiratory rate in acute patients with hypercapnic respiratory failure. Patients admitted to hospital with acute respiratory failure (ARF) will be assessed for hypercapnic ARF by normal hospital protocols. Patients requiring noninvasive ventilation (NIV) will be set up on NIV as prescribed per standard of care. Enrollment onto the investigation will occur after the patient has been allowed to stabilize on NIV . Patients that meet the inclusion/exclusion criteria will be approached for consent. Investigation participants will receive two masks in random order; 1. NIV for one hour with the investigational mask (Vela) 2. NIV for one hour with the standard mask (Nivairo). Participants will have their physiological respiratory parameters recorded.


Clinical Trial Description

This is a simple study. Patients who are already on noninvasive ventilation (NIV) for acute respiratory failure will be approached for the study within the first 24 hours on NIV therapy. The study will be conducted as described above. After the study patients will be able to choose which mask they continue their NIV on. They will continue NIV as part of their normal hospital care. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05964244
Study type Interventional
Source Fisher and Paykel Healthcare
Contact
Status Not yet recruiting
Phase N/A
Start date November 2023
Completion date May 2024

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