Nasal High Flow Versus Non-invasive Ventilation for Early Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Hypercapnic Acidosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity Hospital, Montpellier

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Ventilatory support via nasal high flow

    Device

    Ventilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment.

  • Ventilatory support via NIV

    Device

    Ventilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment.

Treatment groups

174 Participants
are divided into 2 treatment groups
Group A: Nasal high flowExperimental treatment 1 intervention
Group B: Non invasive ventilationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
2 hours

Secondary outcomes

1

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

Time frame
2 hours
2

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

Time frame
2 hours
3

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

Time frame
up to 24 hours
4

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

Time frame
up to 24 hours

Other outcomes

1

Hospitalization rate, including hospitalization in critical care units

Proportion of patients requiring hospitalization following ED management

Time frame
Day 28
2

Readmission for AE-COPD

Proportion of patients requiring emergency department admission for AE-COPD within 28 days from index admission

Time frame
Day 28

Sponsors and contacts

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University Hospital, Montpellier

Lead sponsor

Fisher and Paykel Healthcare

Collaborator