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

NCT04468126 | Completed

• 1 other identifier: SOHO
• Study Type: interventional
• Target: 1,504
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Acute Respiratory Failure; Hypoxemic Respiratory Failure

Keywords

acute hypoxemic respiratory failure; de novo respiratory failure; high-flow nasal oxygen; standard oxygen

Outcome Measures

Primary Outcomes (1)

• Mortality at 28 days after randomization

  Death between randomization and 28 days after randomization

  Day 28

Secondary Outcomes (11)

• Failure of the oxygenation strategy between randomization and D28

  Day 28

• Mortality in ICU, in hospital, and day 90

  Day 90

• Number of ventilation free days at Day 28

  Day 28

• Duration of ICU and hospital stay

  Day 90

• Complications during the ICU stay

  Day 90

Study Arms (2)

standard oxygen group

ACTIVE COMPARATOR

In order to maintain SpO2 between 92 and 96%

Other: Standard oxygen

high-flow nasal cannula oxygen group

EXPERIMENTAL

At least 50 L/min adjusted in order to maintain SpO2 between 92 and 96 %

Other: High-flow nasal oxygen therapy

Interventions

Standard oxygen OTHER

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

standard oxygen group

High-flow nasal oxygen therapy OTHER

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%

high-flow nasal cannula oxygen group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHu Poitiers

Poitiers, 86000, France

Location

Related Publications (3)

• 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 Mar 17. doi: 10.1056/NEJMoa2516087. Online ahead of print.

  PMID: 41841715 DERIVED

• 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.

  PMID: 39448217 DERIVED

• 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.

  PMID: 36166027 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Jean-Pierre FRAT, PhD

  CHU Poitiers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 13, 2020
• Study Start: January 19, 2021
• Primary Completion: October 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)