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

Study Overview
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Brief Summary
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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

Official Title
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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.

Conditions
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Acute Respiratory Failure, Hypoxemic Respiratory Failure

Intervention / Treatment
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* Other: Standard oxygen
* Other: High-flow nasal oxygen therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard oxygen group<br>In order to maintain SpO2 between 92 and 96% | Other: Standard oxygen<br>* Standard low flow oxygen therapy through facemask or non-rebreathing mask at least 10 L/min.<br>|
| Experimental: high-flow nasal cannula oxygen group<br>At least 50 L/min adjusted in order to maintain SpO2 between 92 and 96 % | Other: High-flow nasal oxygen therapy<br>* 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%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality at 28 days after randomization | Death between randomization and 28 days after randomization | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure of the oxygenation strategy between randomization and D28 | Intubation between randomization and D28 | Day 28 | 
| Mortality in ICU, in hospital, and day 90 | Death between randomization and end of stay in ICU, hospital. Death between randomization and day 90. | Day 90 | 
| Number of ventilation free days at Day 28 | days alive and without intubation between day 1 and day 28 | Day 28 | 
| Duration of ICU and hospital stay | ICU and hospital stay between randomisation and end of stay in ICU and hospital | Day 90 | 
| Complications during the ICU stay | Complications during the ICU stay include: septic shock, nosocomial pneumonia, cardiac arrhythmia, and cardiac arrest. | Day 90 | 
| 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) | Hour 6 | 
| Comfort | comfort is evaluated using a 100-mm visual-analogue scale, from 0, i.e. no discomfort, to100, i.e. maximal imaginable discomfort | Hour 6 | 
| Level of oxygenation | Oxygenation is assessed by arterial blood gas sample | Hour 48 | 
| 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. | Day 28 | 
| 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 | Day 28 | 
| Duration between treatment initiation and intubation | Interval between treatment initiation and intubation | Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute hypoxemic respiratory failure, de novo respiratory failure, high-flow nasal oxygen, standard oxygen