NCT06114667Recruiting
Nasal High Flow Versus Non-invasive Ventilation for Early Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Hypercapnic Acidosis
Nasal High Flow in Early Management of Patients Admitted to the Emergency Department for Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Hypercapnic Acidosis : a Randomized Controlled Non Inferiority Study
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 174 (estimated)
- First submitted
- 4 Sept 2023
- Start date
- 16 Jun 2026
- Primary completion date
- 1 Nov 2028
- Lead sponsor
- University Hospital, Montpellier
- Diseases
- COPD
- NCT number
- NCT06114667
What you commit to
- Study type: Interventional
- Planned participants: 174
- From 16 Jun 2026 to the primary completion date, 1 Nov 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have already received NIV treatment before inclusion (including in-hospital or prehospital, with the exception of NIV at home)
Other
- Contraindication to non-invasive ventilation (SPLF 2017 and GOLD 2023 recommendations)
- Patient uncooperative, agitated, opponent of the technique
Who the study is looking for
- 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)
Criteria the registry did not label
- 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)
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Montpellier University Hospital Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Centre Hospitalier Universitaire de Nîmes Coordinator of this site? Confirm its status | Nîmes | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.