Nasal High Flow Versus Non-invasive Ventilation for Early Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Hypercapnic Acidosis
Recruiting · NCT06114667 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Montpellier
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 pulmonary disease (AE-COPD) and hypercapnic acidosis in the emergency department (ED). After obtaining informed consent, participants will be randomly assigned to receive either nasal high flow or non invasive ventilation (NIV, reference treatment) as respiratory support. Researchers will compare both respiratory support groups to see if their blood gas analysis and respiration return to normal ranges.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
3 locations listed.
- Centre hospitalier universitaire de Nimes - Nîmes, France
- Centre Hospitalier Universitaire de Poitiers - Poitiers, France
- Montpellier University Hospital - Montpellier, Montepllier, France