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

Launched by FISHER AND PAYKEL HEALTHCARE · Jul 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new type of mask used in noninvasive ventilation (NIV) to see if it can help reduce the breathing rate of patients with a specific type of respiratory failure called acute hypercapnic respiratory failure. The trial will involve patients who are already in the hospital and have been prescribed NIV as part of their treatment. If eligible, participants will try two different masks: one is the new investigational mask called Vela, and the other is a standard mask called Nivairo. Each participant will wear both masks for one hour while their breathing and other important health measures are recorded.

To be eligible for this trial, participants must be at least 18 years old and diagnosed with type II acute respiratory failure that requires noninvasive ventilation. They also need to have certain lab results showing high levels of carbon dioxide in their blood and a specific level of acidity. Importantly, they must test negative for COVID-19 and have been on NIV for 24 hours or less. This trial aims to gather information that could improve treatment for patients with respiratory failure, and it's not yet recruiting participants at this time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have type II acute respiratory failure (ARF) and have been prescribed NIV
• • Arterial blood gas (ABG) Partial pressure of arterial carbon dioxide greater or equal to 6.0 kilopascals (45 millimeters of mercury)
• • Arterial blood gas acidity greater or equal to 7.35 prior to bilevel commencement
• • On NIV for 24 hours or less
• • Negative Covid-19 test
• • Are 18 years or older
• Exclusion Criteria:
• • Contraindicated for NIV
• • On NIV in Emergency Department/ ward for more than 24 hours, within the last 48 hours
• • NIV is likely to fail and/or intubation be required, at the doctor's discretion
• • CPAP or bilevel pressure of 25 centimeters of water or more is required
• • Unable to tolerate NIV for the duration of the investigation
• • Do not fit the investigational mask or the standard mask
• • Pregnancy (tested under standard care)
• • Agitated
• • Unable to understand the consent process