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Could a simple nasal device replace ventilators for COPD emergencies?

NCT ID NCT06114667

Disease control Sponsor: University Hospital, Montpellier Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a nasal high-flow device to standard non-invasive ventilation (NIV) for treating people who come to the emergency room with a severe COPD flare-up and high carbon dioxide levels. Participants are randomly assigned to receive one of the two breathing supports for two-hour sessions. Researchers measure whether the nasal device is as good as NIV at bringing blood gas levels back to normal.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nasal high flow device
What this could lead to
If successful, this could offer a simpler, more comfortable breathing support option for people with COPD flare-ups in the emergency room.
What could go wrong
This is a single study with 174 participants, and it only looks at early treatment in the emergency department. The nasal high flow may not work as well as standard care for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 174 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acidosis disorder Acidosis, Respiratory chronic obstructive pulmonary disease Emergencies respiratory failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute exacerbation of chronic obstructive pulmonary disease Hypercapnic acidosis Respiratory failure with hypercapnia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre Hospitalier Universitaire de Poitiers

    NOT_YET_RECRUITING

    Poitiers, France

  • Centre hospitalier universitaire de Nimes

    NOT_YET_RECRUITING

    Nîmes, France

  • Montpellier University Hospital

    RECRUITING

    Montpellier, Montepllier, 34000, France

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