Status:
NOT_YET_RECRUITING
NIV With Airway Washout for Dual Limb Ventilation: Improvement in Minute Ventilation
Lead Sponsor:
Fisher and Paykel Healthcare
Conditions:
Respiratory Failure Requiring Non Invasive Ventilation
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief 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 ...
Detailed Description
In an acute setting, Non-invasive ventilation (NIV) is a method of delivering respiratory support without using an endotracheal tube. It's a first-line treatment for specific conditions like COPD exac...
Eligibility Criteria
Inclusion
- Adults admitted to the ICU prescribed NIV and stable
- Able to receive therapy on a sub-nasal (under-the-nose) mask
- Are 18 years old or older
Exclusion
- Contraindicated for NIV
- NIV is likely to fail and/or intubation be required, at the medical staff's discretion
- Bilevel pressure of ≥ 30 cmH2O required
- Do not fit the investigational mask or the standard mask
- Pregnancy (tested under standard care)
- Unable to tolerate NIV for the duration of the investigation
- Agitated
- Unable to understand the consent process
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06939920
Start Date
July 1 2025
End Date
July 1 2026
Last Update
May 22 2025
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