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Can early oxygen therapy prevent breathing failure after chest trauma?

NCT ID NCT03943914

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether giving breathing support early (non-invasive ventilation and high-flow nasal oxygen) to people with chest injuries and low oxygen levels could prevent them from needing a breathing tube. 144 patients in the ICU took part. The goal was to see if this early approach works better than waiting until breathing gets worse.

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

144 people

The number who actually took part.

Started

Sep 2019

Finished

Nov 2021

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: * Patient admitted in intensive care unit within 48 hours after a high-risk blunt chest trauma, defined by a TTS (Thorax Trauma Severity) score ≥ 8. * Hypoxemia defined by a PaO2/FiO2 ratio \< 300, and the absence of hypercapnia (PaCO2 \< 45 mmHg). * Without indication of endotracheal intubation at inclusion. * Affiliated person or beneficiary of a social security scheme. * Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research). Exclusion Criteria: * Criteria relating to formal indication to NIV: Exacerbation of underlying chronic respiratory disease, cardiogenic pulmonary edema, severe neutropenia. * Criteria relating to contraindications to NIV: Hemodynamic instability, Glasgow Coma Scale score ≤ 12 or excessive agitation, or other contraindications to non-invasive ventilation (active gastrointestinal bleeding, low level of consciousness, multiorgan failure, airway patency problems, lack of cooperation or hemodynamic instability). * Associated traumatic lesions entailing particular risks: severe brain injury, complex facial trauma, tetraplegia, tracheobronchial or esophageal injuries, thoracic or abdominal trauma with indication for surgery by thoracotomy or laparotomy. * Criteria relating to the regulation: A do-not-intubate order and a decision not to participate, persons placed under judicial protection, persons participating in another research including a period of exclusion still in course, severely altered physical and/or psychological health which, according to the investigator, could affect the participant's compliance of the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • AP-HM - Hôpital de la Timone

    Marseille, 13385, France

  • APHP - Hôpital Beaujon

    Clichy, 92110, France

  • CH d'Annecy

    Annecy, France

  • CH de Pau

    Pau, 64000, France

  • CHU Amiens-Picardie

    Amiens, 80054, France

  • CHU de Bordeaux

    Bordeaux, 33076, France

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63003, France

  • CHU de Nîmes

    Nîmes, 30029, France

  • CHU de Poitiers

    Poitiers, 86021, France

  • CHU de Saint Etienne

    Saint-Priest-en-Jarez, 42270, France

  • CHU de Strasbourg - Hôpital Civil

    Strasbourg, 67091, France

  • CHU de Strasbourg -Hôpital de Hautepierre

    Strasbourg, 67200, France

  • HCL - Hôpital Lyon Sud

    Pierre-Bénite, 69495, France

  • Hôpital Robert Picqué

    Villenave-d'Ornon, 33882, France

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