Status:
NOT_YET_RECRUITING
Nasal High Flow Versus Non-invasive Ventilation for Early Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Hypercapnic Acidosis
Lead Sponsor:
University Hospital, Montpellier
Collaborating Sponsors:
Fisher and Paykel Healthcare
Conditions:
Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Hypercapnic Acidosis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether nasal high flow is non inferior to non invasive ventilation (NIV) in the early treatment of patients with acute exacerbation of chronic obstructive pu...
Detailed Description
Prospective multicenter comparative therapeutic study, with a randomized controlled parallel and open design. Nasal high flow will be compared to NIV (reference treatment) for early treatment of AE-CO...
Eligibility Criteria
Inclusion
- Adult Patient admitted to the ED for acute exacerbation of COPD (AE-COPD)and respiratory acidosis (PaCO2 \> 45 mmHg and pH \<7.35), for whom ventilatory assistance by NIV is indicated (SPLF 2017, GOLD2023 recommendations)
- Patients with ability to understand and give an informed consent
- Patients affiliated with or who benefit from a social security
- Patients admitted to the emergency department for a clinical suspicion of AE-COPD based on clinical history, physical examination and chest X-ray (SPLF 2017)
- Patients with acute respiratory failure defined by: Respiratory rate ≥ 25 bpm AND/OR Signs of respiratory failure (use of accessory respiratory muscles, paradoxical abdominal movement)
- Patients with respiratory acidosis defined by PaCO2 \> 45 mmHg AND pH \< 7.35 (measured on arterial blood gas)
Exclusion
- Patients who have already received NIV treatment before inclusion (including in-hospital or prehospital, with the exception of NIV at home)
- Contraindication to non-invasive ventilation (SPLF 2017 and GOLD 2023 recommendations)
- Patient uncooperative, agitated, opponent of the technique
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT06114667
Start Date
November 1 2025
End Date
November 1 2028
Last Update
July 8 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre hospitalier universitaire de Montpellier
Montpellier, France
2
Centre hospitalier universitaire de Nimes
Nîmes, France
3
Centre Hospitalier Universitaire de Poitiers
Poitiers, France