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

NCT ID: NCT04468126

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1504 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-19
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

standard oxygen group

In order to maintain SpO2 between 92 and 96%

Group Type: ACTIVE_COMPARATOR

Standard oxygen

Intervention Type: OTHER

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

high-flow nasal cannula oxygen group

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

Group Type: EXPERIMENTAL

High-flow nasal oxygen therapy

Intervention Type: 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%

Interventions

Standard oxygen

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

Intervention Type: OTHER

High-flow nasal oxygen therapy

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%

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Pierre FRAT, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Poitiers

Locations

CHu Poitiers

Poitiers, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 39448217 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36166027 (View on PubMed)

Other Identifiers

SOHO

Identifier Type: -

Identifier Source: org_study_id