Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06114667

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montpellier University Hospital, Montpellier, Montepllier, France

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Adult Patient admitted to the ED for acute exacerbation of COPD (AE-COPD)and respiratory acidosis (PaCO2 > 45 mmHg and pH <7.35), for whom ventilatory assistance by NIV is indicated (SPLF 2017, GOLD2023 recommendations)

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

Treatment and study plan

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.

Primary outcomes

  1. Change in PaCO2

    Time frame: 2 hours

    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

  1. Change in pH

    Time frame: 2 hours

    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

  2. Change in PaO2

    Time frame: 2 hours

    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

  3. Change in PaCO2

    Time frame: up to 24 hours

    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

  4. Change in pH

    Time frame: up to 24 hours

    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

  5. Change in PaO2

    Time frame: up to 24 hours

    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

  6. Respiratory rate

    Time frame: up to 24 hours

    Clinical parameters will be monitored by physician at baseline and throughout ventilatory support sessions, according to the international guidelines for NIV monitoring

  7. Signs of increased work of breathing (use of accessory respiratory muscles, paradoxical motion of the abdomen)

    Time frame: up to 24 hours

    Use of accessory respiratory muscles and paradoxical motion of the abdomen will be assessed by physician at baseline and after sessions of ventilatory support, on a 5 point likert scale (from 1 : absence to 5 : maximal use or accessory respiratory muscle and paradoxical motion of the abdomen)

  8. Perceived dyspnea

    Time frame: up to 24 hours

    Dyspnea will be assessed by the patient using a Modified Borg scale for dyspnea, at baseline and after sessions of ventilatory support. Difficulty of breathing will be quantified on a scale from 0 : no difficulty at all to 10 : breathing difficulty is maximal.

  9. Treatment failure (composite of change of treatment arm / need for invasive mechanical ventilation/ mortality)

    Time frame: Up to Day 28

    Failure will be defined by a composite of clinical or gasometric worsening or patient intolerance inducing a change of treatment arm/ need for orotracheal intubation and/or mortality (all causes).

  10. Weaning from ventilatory support

    Time frame: Up to Day 28

    Delay from initiation of ventilatory support to weaning

Other outcomes

  1. Hospitalization rate, including hospitalization in critical care units

    Time frame: Day 28

    Proportion of patients requiring hospitalization following ED management

  2. Readmission for AE-COPD

    Time frame: Day 28

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mustapha Sebbane, MD, PhD

CONTACT

[email protected]

+33 (4) 67 33 85 76

Sophie LEFEBVRE, PhD

CONTACT

[email protected]

+33 (4) 67 33 85 76

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Fisher and Paykel Healthcare

Registry information

Official study title

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

Acronym: HiCOPD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 2, 2023
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.