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Which oxygen method saves more lives? large trial tests standard vs High-Flow

NCT ID NCT04468126

Disease control Sponsor: Poitiers University Hospital 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 high-flow heated oxygen through nasal prongs helps more people survive severe breathing failure than standard oxygen masks. Over 1,500 adults with low blood oxygen levels were randomly assigned to one of the two oxygen methods. The main goal was to see who was alive 28 days later.

What this could mean

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

Active substance
oxygen therapy (standard low-flow oxygen vs high-flow nasal cannula oxygen)
What this could lead to
If high-flow oxygen proves better, it could become the standard first-line oxygen therapy for acute respiratory failure, potentially reducing deaths.
What could go wrong
This trial is completed but results are not yet widely implemented; earlier studies showed mixed results, especially in immunocompromised patients, so the benefit may not be universal.

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

1,504 people

The number who actually took part.

Started

Jan 2021

Finished

Dec 2024

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: All consecutive patients older than 18 years with an acute hypoxemic respiratory failure will be enrolled if they meet all the following criteria: * Respiratory rate \>25 breaths/min whatever the oxygen support * Pulmonary infiltrate, * PaO2/FiO2 ≤200 mmHg * Informed consent from the patient or relatives. Exclusion Criteria: * PaCO2 \> 45 mm Hg * Need for emergent intubation: pulse oximetry \< 90% with maximum oxygen support, respiratory arrest, cardiac arrest, or Glasgow coma scale below 8 points * Hemodynamic instability defined by signs of hypoperfusion or use of vasopressors \> 0.3 µg/kg/min * Glasgow coma scale equal to or below 12 points * Exacerbation of chronic lung disease including chronic obstructive pulmonary disease (grade 3 or 4 of Gold classification), or another chronic lung disease with long term oxygen or ventilatory support * Cardiogenic pulmonary edema as main reason for acute respiratory failure * Coronavirus SARS-2 infection as reason for acute respiratory failure (the SOHO-COVID study has been completed) * Post-extubation respiratory failure within 7 days after extubation, * Post-operative patients within 7 days after abdominal or cardiothoracic surgery, * Do not intubate order; * Already included in the study, refusal to participate or participation in another interventional study with the same primary outcome. * Patients without any healthcare insurance scheme or not benefiting from it through a third party, * Persons under law protection, namely minors, pregnant or breastfeeding women, persons deprived of their liberty by a judicial or administrative decision.

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Conditions

The condition(s) this trial relates to.

acute respiratory failure respiratory failure

As listed by the trial registrant

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

Acute respiratory failure Hypoxemic respiratory failure

Contacts and locations

Locations

  • CHu Poitiers

    Poitiers, 86000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.