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Completed

NCT Number: NCT04468126

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHu Poitiers

Poitiers, 86000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard oxygen

Other

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

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%

Primary outcomes

  1. Mortality at 28 days after randomization

    Time frame: Day 28

    Death between randomization and 28 days after randomization

Secondary outcomes

  1. Failure of the oxygenation strategy between randomization and D28

    Time frame: Day 28

    Intubation between randomization and D28

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

    Time frame: Day 90

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

  3. Number of ventilation free days at Day 28

    Time frame: Day 28

    days alive and without intubation between day 1 and day 28

  4. Duration of ICU and hospital stay

    Time frame: Day 90

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

  5. Complications during the ICU stay

    Time frame: Day 90

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

  6. Dyspnea

    Time frame: Hour 1

    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)

  7. Comfort

    Time frame: Hour [1;6]

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

  8. Level of oxygenation

    Time frame: Hour [1;6]

    Oxygenation is assessed by arterial blood gas sample

  9. Organ Failure during the 48 hours after intubation.

    Time frame: Day 28

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

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

    Time frame: Day 28

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

  11. Duration between treatment initiation and intubation

    Time frame: Day 28

    Interval between treatment initiation and intubation

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study 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.

Acronym: SOHO

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 13, 2020
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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