NCT06114667

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Prospective multicenter comparative therapeutic study, with a randomized controlled parallel and open design. Nasal high flow will be compared to NIV (reference treatment) for early treatment of AE-COPD associated with hypercapnic acidosis. Adult patients admitted to the ED for AE-COPD with hypercapnic acidosis will be randomized to receive either nasal high flow or NIV as ventilatory support. Ventilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment. Close monitoring of clinical and gas parameters will be conducted with repeat assessment and serial blood gas testing at 2h and after each 2h session of respiratory support in the ED (2h, 4h, 6h) and at 24h. Standard oxygen therapy will be administered as required between ventilatory support sessions to maintain a target peripheral oxygen saturation (SpO2 : 88-92%). Patient's dyspnea and comfort will be assessed before treatment and at 2h, and after each respiratory support session in the ED Patients will receive standard medical treatment for AE-COPD (bronchodilator, corticosteroids and antibiotics) according to current practice and 2023 global initiative guidelines for the management of COPD (GOLD). Patients will be followed up at day 28 by means of medical records review and telephone interview

Conditions

• Acute Exacerbation of Chronic Obstructive Pulmonary Disease
• Hypercapnic Acidosis
• Respiratory Failure With Hypercapnia

Interventions

Type	Name	Description
DEVICE	Ventilatory support via nasal high flow	Ventilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment.
DEVICE	Ventilatory support via NIV	Ventilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment.

Timeline

• Start date: 2025-11-01
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2023-11-02
• Last updated: 2025-07-08

Locations

3 sites across 1 country: France