Status:
UNKNOWN
Impact of Noninvasive With Expiratory Washout on Respiratory Rate of Patients With Acute Hypercapnic Respiratory Failure
Lead Sponsor:
Fisher and Paykel Healthcare
Conditions:
Noninvasive Ventilation
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief 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 respirator...
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05964244
Start Date
November 1 2023
End Date
May 1 2024
Last Update
July 27 2023
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