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

NCT ID: NCT06114667

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2028-11-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nasal high flow

Nasal high flow will be administered through a heated humidifier (Airvo 3, Fisher and Paykel healthcare) and applied through large bore binasal prongs.

Initial gas flow rate will be set at 60 l/min, FiO2 will be adjusted to maintain an SpO2 88-92% and Initial temperature will be set at 37° and reduced according to patient's tolerance.

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

Group Type: EXPERIMENTAL

Ventilatory support via nasal high flow

Intervention Type: DEVICE

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

Non invasive ventilation

NIV will be delivered through a face mask connected to a ventilator with pressure support applied in a noninvasive ventilation mode.

The Pressure-support level will be adjusted to obtain an expired tidal volume of 6-8 ml/kg of predicted body weight and a respiratory rate of 25-30 b/min. PEEP (range 5-10 cm of water) and FiO2 will be adjusted to maintain an SpO2 88-92% and to patient's comfort.

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

Group Type: ACTIVE_COMPARATOR

Ventilatory support via NIV

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Ventilatory support via NIV

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mustapha Sebbane, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Centre hospitalier universitaire de Montpellier

Montpellier, , France

Centre hospitalier universitaire de Nimes

Nîmes, , France

Centre Hospitalier Universitaire de Poitiers

Poitiers, , France

Countries

France

Central Contacts

Mustapha Sebbane, MD, PhD

Role: CONTACT

m-sebbane@chu-montpellier.fr

+33 (4) 67 33 85 76

Sophie LEFEBVRE, PhD

Role: CONTACT

s-lefebvre@chu-montpellier.fr

+33 (4) 67 33 85 76

Facility Contacts

Pierre-Géraud Claret, MD, PhD

Role: primary

Nicolas Marjanovic, MD, PhD

Role: primary

Other Identifiers

2022-A02633-40

Identifier Type: REGISTRY

Identifier Source: secondary_id

RECHMPL19_0626

Identifier Type: -

Identifier Source: org_study_id