Nasal High Flow vs NIV for early treatment of AE-COPD with high CO2

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, open-label study compares nasal high flow to non-invasive ventilation as early respiratory support for adults with AE-COPD and hypercapnic acidosis in the ED. Participants are assigned to receive either nasal high flow or NIV in 2-hour sessions with ongoing monitoring and serial blood gas testing to see if gas exchange and respiration normalize. Standard COPD care is provided per current guidelines, and follow-up occurs at 28 days via medical records and phone contact.

Why it matters

Who can join: the full rules

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)

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's running

• Montpellier University Hospital
  Montpellier, Montepllier, France Recruiting
• Centre hospitalier universitaire de Nimes
  Nîmes, France Not yet recruiting
• Centre Hospitalier Universitaire de Poitiers
  Poitiers, France Not yet recruiting

Study contacts

• Principal investigator: Mustapha Sebbane, MD, PhD — University Hospital, Montpellier
• Study coordinator: Mustapha Sebbane, MD, PhD
• Email: m-sebbane@chu-montpellier.fr
• Phone: +33 (4) 67 33 85 76

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.