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

NCT06114667 | Not Yet Recruiting

• 2 other identifiers: RECHMPL19_06262022-A02633-40
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

respiratory insufficiency; Hypercapnic Acute Respiratory Failure; chronic obstructive pulmonary disease exacerbation; nasal high flow; non invasive ventilation; emergency department; critical are

Outcome Measures

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

  2 hours

Secondary Outcomes (10)

• Change in pH

  2 hours

• Change in PaO2

  2 hours

• Change in PaCO2

  up to 24 hours

• Change in pH

  up to 24 hours

• Change in PaO2

  up to 24 hours

Other Outcomes (2)

• Hospitalization rate, including hospitalization in critical care units

  Day 28

• Readmission for AE-COPD

  Day 28

Study Arms (2)

Nasal high flow

EXPERIMENTAL

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

Device: Ventilatory support via nasal high flow

Non invasive ventilation

ACTIVE COMPARATOR

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.

Device: Ventilatory support via NIV

Interventions

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.

Nasal high flow

Ventilatory support via NIV DEVICE

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

Non invasive ventilation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Contraindication to non-invasive ventilation (SPLF 2017 and GOLD 2023 recommendations)
• Patient uncooperative, agitated, opponent of the technique

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Fisher and Paykel Healthcare: collaborator

Study Sites (3)

Centre hospitalier universitaire de Montpellier

Montpellier, France

Location

Centre hospitalier universitaire de Nimes

Nîmes, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, France

Location

MeSH Terms

Conditions

Acidosis, Respiratory; Respiratory Insufficiency; Emergencies

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mustapha Sebbane, MD, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustapha Sebbane, MD, PhD

CONTACT

+33 (4) 67 33 85 76; m-sebbane@chu-montpellier.fr

Sophie LEFEBVRE, PhD

CONTACT

+33 (4) 67 33 85 76; s-lefebvre@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking non feasible
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to either one of two groups of respiratory support (NIV or nasal high flow) in parallel. Randomization will be in a 1:1 ratio, and stratified by center, severity of hypercapnia and acidosis

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: November 2, 2023
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

FR (3)