About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Ventilatory support via nasal high flow
DeviceVentilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment.
Ventilatory support via NIV
DeviceVentilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment.
Treatment groups
Trial outcomes
Primary outcomes
Change in PaCO2
PaCO2 will be measured from standard laboratory arterial blood gas analysis before the initiation of ventilatory assistance and after 2 hours of treatment
Secondary outcomes
Change in pH
Blood gas parameters will be measured from standard laboratory arterial blood gas analysis before the initiation of ventilatory support and after 2 hours of treatment
Change in PaO2
Blood gas parameters will be measured from standard laboratory arterial blood gas analysis before the initiation of ventilatory support and after 2 hours of treatment
Change in PaCO2
Blood gas parameters will be measured from standard laboratory arterial blood gas analysis before the initiation of ventilatory support and after sessions of ventilatory support
Change in pH
Blood gas parameters will be measured from standard laboratory arterial blood gas analysis before the initiation of ventilatory support and after sessions of ventilatory support
Other outcomes
Hospitalization rate, including hospitalization in critical care units
Proportion of patients requiring hospitalization following ED management
Readmission for AE-COPD
Proportion of patients requiring emergency department admission for AE-COPD within 28 days from index admission
Sponsors and contacts
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University Hospital, Montpellier
Lead sponsor
Fisher and Paykel Healthcare
Collaborator