NCT05964244

Impact of Noninvasive With Expiratory Washout on Respiratory Rate of Patients With Acute Hypercapnic Respiratory Failure

Evaluate the Impact of Noninvasive (NIV) With Expiratory Washout on Respiratory Rate of Patients With Acute Hypercapnic Respiratory Failure. A Prospective, Randomized Cross Over Pilot Investigation.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Noninvasive Ventilation

Interventions

Type	Name	Description
DEVICE	Vela Investigational Mask	Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy.
DEVICE	Nivairo Standard Mask	Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2023-07-27
• Last updated: 2023-07-27