Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseHiCOPDNCT06114667
Nasal High Flow Versus Non-invasive Ventilation for Early Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Hypercapnic Acidosis
A study testing Ventilatory support via nasal high flow and Ventilatory support via NIV in people with Acute Exacerbation of Chronic Obstructive Pulmonary Disease and Hypercapnic Acidosis, run by University Hospital, Montpellier at 3 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Hypercapnic Acidosis, Respiratory Failure With Hypercapnia
- What is being tested?
- Ventilatory support via nasal high flow and Ventilatory support via NIV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 3 sitesFrance
- Study dates
- 16 Jun 2026to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Montpellier University Hospital
Montpellier, Montepllier, 34000
MUSTAPHA SEBBANE, +33 667337974, m-sebbane@chu-montpellier.fr
- Not yet recruiting
Centre hospitalier universitaire de Nimes
Nîmes
Pierre-Géraud Claret, MD, PhD
- Not yet recruiting
Centre Hospitalier Universitaire de Poitiers
Poitiers
Nicolas Marjanovic, MD, PhD
About this study
Official 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
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.
Read the 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
- Being tested
- Ventilatory support via nasal high flow, Ventilatory support via NIV
- Keywords
- respiratory insufficiency, Hypercapnic Acute Respiratory Failure, chronic obstructive pulmonary disease exacerbation, nasal high flow, non invasive ventilation, emergency department, critical are
- Medical subject headings
- Acidosis, Respiratory, Respiratory Insufficiency, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilatory support via nasal high flowDevice
Ventilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment.
Ventilatory support via NIVDevice
Ventilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Ventilatory support via NIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 hours
Secondary outcomes (10)
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
Measured: 2 hours
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
Measured: 2 hours
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
Measured: up to 24 hours
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
Measured: up to 24 hours
Change in PaO2
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
Measured: up to 24 hours
Respiratory rate
Clinical parameters will be monitored by physician at baseline and throughout ventilatory support sessions, according to the international guidelines for NIV monitoring
Measured: up to 24 hours
Signs of increased work of breathing (use of accessory respiratory muscles, paradoxical motion of the abdomen)
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)
Measured: up to 24 hours
Perceived dyspnea
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.
Measured: up to 24 hours
Treatment failure (composite of change of treatment arm / need for invasive mechanical ventilation/ mortality)
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).
Measured: Up to Day 28
Weaning from ventilatory support
Delay from initiation of ventilatory support to weaning
Measured: Up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start16 Jun 2026
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Sponsor
- Investigators
- Mustapha Sebbane, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114667
- Sponsor's protocol ID
- RECHMPL19_0626
- Other IDs
- 2022-A02633-40
- Acronym
- HiCOPD
- Status last verified
- Jun 2026
- First submitted
- 4 Sep 2023
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06114667
- Acronym / sponsor ID
- HiCOPD / RECHMPL19_0626
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Nasal high flow | Experimental | Device: Ventilatory support via nasal high flowNasal 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 |
| Non invasive ventilation | Active comparator | Device: Ventilatory support via NIVNIV 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventilatory support via nasal high flowVentilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment. | Device | Nasal high flow |
| Ventilatory support via NIVVentilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment. | Device | Non invasive ventilation |
Primary outcome
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
10 secondary outcomes
Change in pH
Time frame: 2 hours
Change in PaO2
Time frame: 2 hours
Change in PaCO2
Time frame: up to 24 hours
Change in pH
Time frame: up to 24 hours
Change in PaO2
Time frame: up to 24 hours
Respiratory rate
Time frame: up to 24 hours
Signs of increased work of breathing (use of accessory respiratory muscles, paradoxical motion of the abdomen)
Time frame: up to 24 hours
Perceived dyspnea
Time frame: up to 24 hours
Treatment failure (composite of change of treatment arm / need for invasive mechanical ventilation/ mortality)
Time frame: Up to Day 28
Weaning from ventilatory support
Time frame: Up to Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mustapha Sebbane, MD, PhD principal investigator
University Hospital, Montpellier
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilatory support via nasal high flow and Ventilatory support via NIV in people with Acute Exacerbation of Chronic Obstructive Pulmonary Disease and Hypercapnic Acidosis, run by University Hospital, Montpellier at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mustapha Sebbane, MD, PhD (+33 (4) 67 33 85 76, m-sebbane@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PaCO2 (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.