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Nasal High-Flow device tested for breathing trouble

NCT ID NCT06008587

Symptom relief Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 tested a device that delivers warm, moist air through the nose to help people with breathing failure who did not have too much acid in their blood. The goal was to see if it could prevent their condition from getting worse. Only 16 people took part, and the study was stopped early, so the results are not strong enough to draw clear conclusions.

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 (AIRVO3 TM)
What this could lead to
If it works, this could offer a gentler breathing support option for some patients with respiratory failure.
What could go wrong
The trial was terminated early with only 16 participants, so results are very limited. It is unclear if the device helps more than standard care.

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

16 people

The number who actually took part.

Started

Feb 2024

Finished

Sep 2025

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 years and older

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.

Inclusion Criteria: * Major patient ≥ 18 years old * Medical diagnosis of Acute Respiratory Failure less than 48 hours * With partial pressure of carbon dioxide (PaCO2) \> 45 and pH \> 7.35 for less than 48 hours, with no indication of Non-Invasive Ventilation (NIV) placement * Underlying terrain of known or unknown chronic respiratory pathology (may be unknown at time of diagnosis) Examples : COPD, Bronchiectasis, Pulmonary fibrosis, asthma, sequelae pathologies … * All etiologies (infectious, cardiac decompensation, trauma, etc.) * Having given informed consent * Patient under a social security scheme * Possibility to include a patient having already been included in the study but suffering from a new episode of hypercapnic non acidic Acute Respiratory Failure with a free interval of 3 months Exclusion Criteria: * Restrictive chronic neuromuscular or kyphoscoliotic respiratory insufficiencies * Drug-induced Acute respiratory failure * Pneumothorax (X-ray pulmonary detachment) * Oxygen poisoning. In this case, PaCO2 will be asset again later with the purpose to include after oxygenotherapy decrease for a target SpO2 of 92% maximum * Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (COVII) Pneumonia * Tracheostomy * Prior treatment with chronic or initiated NIV just prior to treatment (e.g. Intensive Care Unit) * Respiratory Severity Criteria for Resuscitation Management * Agitation or non-cooperation * Pregnancy or breastfeeding * Person participating in other biomedical research * Any other reason that the investigator believes may interfere with the evaluation of the study objectives * Person under judicial protection (guardianship, curatorship) * Person deprived of liberty by a judicial or administrative decision

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Conditions

The condition(s) this trial relates to.

acute respiratory failure Hypercapnia respiratory failure

As listed by the trial registrant

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

Respiratory insufficiency

Contacts and locations

Locations

  • Centre Hospitalier Intercommunal de Toulon- La Seyne sur Mer - Hôpital Sainte Musse

    Toulon, Var, 83100, France

  • Centre Hospitalier Princesse Grace

    Monaco, 98000, Monaco

  • Centre Hospitalier de Cannes

    Cannes, Alpes Maritime, 06400, France

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