SOHO: Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: standard oxygen group In order to maintain SpO2 between 92 and 96% |
Other: Standard oxygen
Standard low flow oxygen therapy through facemask or non-rebreathing mask at least 10 L/min.
|
| Experimental: high-flow nasal cannula oxygen group At least 50 L/min adjusted in order to maintain SpO2 between 92 and 96 % |
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%
|
Outcome Measures
Primary Outcome Measures
- Mortality at 28 days after randomization [Day 28]
Death between randomization and 28 days after randomization
Secondary Outcome Measures
- Failure of the oxygenation strategy between randomization and D28 [Day 28]
Intubation between randomization and D28
- Mortality in ICU, in hospital, and day 90 [Day 90]
Death between randomization and end of stay in ICU, hospital. Death between randomization and day 90.
- Number of ventilation free days at Day 28 [Day 28]
days alive and without intubation between day 1 and day 28
- Duration of ICU and hospital stay [Day 90]
ICU and hospital stay between randomisation and end of stay in ICU and hospital
- Complications during the ICU stay [Day 90]
Complications during the ICU stay include: septic shock, nosocomial pneumonia, cardiac arrhythmia, and cardiac arrest.
- Dyspnea [Hour 6]
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)
- Comfort [Hour 6]
comfort is evaluated using a 100-mm visual-analogue scale, from 0, i.e. "no discomfort", to100, i.e. "maximal imaginable discomfort"
- Level of oxygenation [Hour 48]
Oxygenation is assessed by arterial blood gas sample
- Organ Failure during the 48 hours after intubation. [Day 28]
Organ failure is evaluated by the Sepsis-related Organ Failure Assessment (SOFA) score during the 48 hours after intubation.
- Duration between the time when prespecified criteria of intubation are met and intubation [Day 28]
interval between the time when prespecified criteria of intubation are met and intubation
- Duration between treatment initiation and intubation [Day 28]
Interval between treatment initiation and intubation
Eligibility Criteria
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:
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Respiratory rate >25 breaths/min (whatever the oxygen support) in COVID-negative patient, non relevant in COVID-positive patient
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Pulmonary infiltrate,
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PaO2/FiO2 ≤200 mmHg
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Informed consent from the patient or relatives.
Exclusion Criteria:
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PaCO2 > 45 mm Hg
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Need for emergent intubation: pulse oximetry < 90% with maximum oxygen support, respiratory arrest, cardiac arrest, or Glasgow coma scale below 8 points
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Hemodynamic instability defined by signs of hypoperfusion or use of vasopressors > 0.3 µg/kg/min
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Glasgow coma scale equal to or below 12 points
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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
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Cardiogenic pulmonary edema as main reason for acute respiratory failure
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Post-extubation respiratory failure within 7 days after extubation,
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Post-operative patients within 7 days after abdominal or cardiothoracic surgery,
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Do not intubate order;
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Already included in the study, refusal to participate or participation in another interventional study with the same primary outcome.
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Patients without any healthcare insurance scheme or not benefiting from it through a third party,
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Persons under law protection, namely minors, pregnant or breastfeeding women, persons deprived of their liberty by a judicial or administrative decision.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHu Poitiers | Poitiers | France | 86000 |
Sponsors and Collaborators
- Poitiers University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SOHO