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Acute Respiratory FailureSOHONCT04468126

Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure

A study testing Standard oxygen and High-flow nasal oxygen therapy in people with Acute Respiratory Failure and Hypoxemic Respiratory Failure, run by Poitiers University Hospital at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

First-line therapy of patients with acute respiratory failure consists in oxygen delivery through standard oxygen, high-flow nasal oxygen therapy through cannula or non-invasive ventilation. Non-invasive ventilation in acute hypoxemic respiratory failure is not recommended. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Standard oxygen and High-flow nasal oxygen therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,504 participants
Where
1 siteFrance
Study dates
19 Jan 2021to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHu Poitiers

    Poitiers, 86000

Other trials in France

About this study

Official title: Impact on Mortality of an Oxygenation Strategy Including Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure: a Prospective, Randomized Controlled Trial.

First-line therapy of patients with acute respiratory failure consists in oxygen delivery through standard oxygen, high-flow nasal oxygen therapy through cannula or non-invasive ventilation. Non-invasive ventilation in acute hypoxemic respiratory failure is not recommended. In a large randomized controlled study, high-flow nasal oxygen has been described as superior to non-invasive ventilation and standard oxygen in terms of mortality but not of intubation. Paradoxically in immunocompromised patients, high-flow nasal oxygen has not been shown to be superior to standard oxygen. To improve the level of evidence of daily clinical practice, we propose comparing high-flow nasal oxygen versus standard oxygen, in terms of mortality in all patients with acute hypoxemic respiratory failure

Being tested
Standard oxygen, High-flow nasal oxygen therapy
Keywords
acute hypoxemic respiratory failure, de novo respiratory failure, high-flow nasal oxygen, standard oxygen
Medical subject headings
Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard oxygenOther

    Standard low flow oxygen therapy through facemask or non-rebreathing mask at least 10 L/min.

  • High-flow nasal oxygen therapyOther

    Humidified and heated oxygen with a gas flow at least 50 l/min through nasal cannula and inspired fraction of oxygen adjusted in order to maintain a SpO2 between 92 and 96%

Study groups in NCT04468126
Study groupRoleWhat they receive
standard oxygen groupActive comparatorIn order to maintain SpO2 between 92 and 96%
Receives: Other: Standard oxygen
high-flow nasal cannula oxygen groupExperimentalAt least 50 L/min adjusted in order to maintain SpO2 between 92 and 96 %
Receives: Other: High-flow nasal oxygen therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality at 28 days after randomization

    Death between randomization and 28 days after randomization

    Measured: Day 28

Secondary outcomes (11)

  1. Failure of the oxygenation strategy between randomization and D28

    Intubation between randomization and D28

    Measured: Day 28

  2. Mortality in ICU, in hospital, and day 90

    Death between randomization and end of stay in ICU, hospital. Death between randomization and day 90.

    Measured: Day 90

  3. Number of ventilation free days at Day 28

    days alive and without intubation between day 1 and day 28

    Measured: Day 28

  4. Duration of ICU and hospital stay

    ICU and hospital stay between randomisation and end of stay in ICU and hospital

    Measured: Day 90

  5. Complications during the ICU stay

    Complications during the ICU stay include: septic shock, nosocomial pneumonia, cardiac arrhythmia, and cardiac arrest.

    Measured: Day 90

  6. Dyspnea

    feeling is evaluated using a 5-point Likert scale, indicating marked improvement (+2), slight improvement (+1), no change (0), slight deterioration (-1) and marked deterioration (-2)

    Measured: Hour 1

  7. Comfort

    comfort is evaluated using a 100-mm visual-analogue scale, from 0, i.e. "no discomfort", to100, i.e. "maximal imaginable discomfort"

    Measured: Hour [1;6]

  8. Level of oxygenation

    Oxygenation is assessed by arterial blood gas sample

    Measured: Hour [1;6]

  9. Organ Failure during the 48 hours after intubation.

    Organ failure is evaluated by the Sepsis-related Organ Failure Assessment (SOFA) score during the 48 hours after intubation.

    Measured: Day 28

  10. Duration between the time when prespecified criteria of intubation are met and intubation

    interval between the time when prespecified criteria of intubation are met and intubation

    Measured: Day 28

  11. Duration between treatment initiation and intubation

    Interval between treatment initiation and intubation

    Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2020
  2. Study start19 Jan 2021
  3. Primary completion30 Oct 2024
  4. Study completion31 Dec 2024

Resources

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,504 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04468126
Sponsor's protocol ID
SOHO
Acronym
SOHO
Status last verified
Jan 2026
First submitted
8 Jul 2020
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Our institution does not have a data sharing platform.

Publications

  • Frat JP, Quenot JP, Guitton C, Coudroy R, Gacouin A, Badie J, Demoule A, Contou D, Carteaux G, Ehrmann S, Jarousseau F, Sedillot N, Rigaud JP, Reignier J, Beloncle F, Dureau AF, Ferre A, Daubin C, Bourreau A, Delbove A, Pradel G, Fatah A, Colin G, Deniel G, Lamouret O, La Combe B, Prat G, Galerneau LM, Bourdin G, Julien G, Curtiaud A, Saint-Leger M, Turbil E, Reynaud F, Chamblet L, Ragot S, Thille AW; SOHO Trial Group and the REVA Network. High-Flow or Standard Oxygen in Acute Hypoxemic Respiratory Failure. N Engl J Med. 2026 Jun 4;394(21):2095-2106. doi: 10.1056/NEJMoa2516087. Epub 2026 Mar 17.

    PubMed 41841715

  • Frat JP, Coudroy R, Quenot JP, Guitton C, Badie J, Gacouin A, Ehrmann S, Demoule A, Jarousseau F, Carteaux G, Rigaud JP, Reignier J, Sedillot N, Contou D, Beloncle F, Daubin C, Dureau AF, Fatah A, Besse MC, Ferre A, Turbil E, Merdji H, Galerneau LM, Lacombe B, Richard JC, Romen A, Delbove A, Prat G, Lautrette A, Colin G, Soum E, Bourdin G, Hernandez G, Ragot S, Thille AW; REVA network. Effect of high-flow nasal cannula oxygen versus standard oxygen on mortality in patients with acute hypoxaemic respiratory failure: protocol for a multicentre, randomised controlled trial (SOHO). BMJ Open. 2024 Oct 23;14(10):e083232. doi: 10.1136/bmjopen-2023-083232.

    PubMed 39448217

  • Frat JP, Quenot JP, Badie J, Coudroy R, Guitton C, Ehrmann S, Gacouin A, Merdji H, Auchabie J, Daubin C, Dureau AF, Thibault L, Sedillot N, Rigaud JP, Demoule A, Fatah A, Terzi N, Simonin M, Danjou W, Carteaux G, Guesdon C, Pradel G, Besse MC, Reignier J, Beloncle F, La Combe B, Prat G, Nay MA, de Keizer J, Ragot S, Thille AW; SOHO-COVID Study Group and the REVA Network. Effect of High-Flow Nasal Cannula Oxygen vs Standard Oxygen Therapy on Mortality in Patients With Respiratory Failure Due to COVID-19: The SOHO-COVID Randomized Clinical Trial. JAMA. 2022 Sep 27;328(12):1212-1222. doi: 10.1001/jama.2022.15613.

    PubMed 36166027

Questions about this trial

What is this clinical trial studying?

A study testing Standard oxygen and High-flow nasal oxygen therapy in people with Acute Respiratory Failure and Hypoxemic Respiratory Failure, run by Poitiers University Hospital at 1 site 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 13 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: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality at 28 days after randomization (time frame: Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04468126, which also lists 3 linked publications.

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 Jan 2026.

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