Comparison of Non-invasive Oxygenation Strategies in Patients Admitted for Covid-19 Acute Respiratory Distress Syndrome

Study Overview
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Brief Summary
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Acute Respiratory Distress Syndrome (ARDS) is the main clinical presentation of SARS-CoV-2 (Covid-19) infected patients admitted in Intensive Care Unit (ICU). During the first phase of the outbreak (between February and May 2020), the use of invasive Mechanical Ventilation (MV) was largely required with 63% of ICU patients intubated in the first 24 hours after admission and up to 80% of patients during the overall ICU stay. Mortality was especially higher when using MV in the first 24 hours. In contrast, the use of non-invasive oxygenation strategies in the first 24 hours was only 19% for High Flow Nasal Cannula oxygen therapy (HFNC) and 6% for Non-Invasive Ventilation (NIV). Several non-invasive oxygenation strategies were proposed in order to delay or avoid MV in ICU patients suffering from Covid-19 ARDS. The use of HFNC became the recommended oxygenation strategy, based in particular on publications prior to the outbreak. The use of NIV or Continuous Positive Airway Pressure (CPAP) combined with HFNC have also been proposed. Although these non-invasive oxygenation strategies seem widely used in the second phase of the outbreak, they have not yet confirmed their clinical impact on MV requirement and patient's outcome. Moreover, no comparison has been made between these different non-invasive oxygenation strategies. The aim of this study is to compare different non-invasive oxygenation strategies (HFNC, NIV, CPAP) on MV requirement and outcome in ICU patients treated for ARDS related to Covid-19.

Detailed Description
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Retrospective multicenter observational registry in French intensive care unit including all consecutive patients admitted for acute respiratory distress syndrome related to SARS-CoV-2 pneumonia between1st July and 31th December 2020. Patients characteristics, ICU treatments and outcome will be recorded.

Official Title
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Comparison of Non-invasive Oxygenation Strategies in ICU Patients Admitted for Covid-19 Acute Respiratory Distress Syndrome

Conditions
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Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Intervention / Treatment
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* Other: Use of High Flow Nasal Cannula alone
* Other: Use of Non-invasive Ventilation
* Other: Use of Continuous Positive Airway Pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients admitted in intensive care unit because of a SARS-CoV-2 infection confirmed by PCR wherever was collected the analyzed sample acute respiratory distress syndrome according to Berlin criteria age superior or equal to 18 years old Exclusion Criteria: patient opposition to participate in the study patients under judicial protection measures

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High Flow Nasal Cannula oxygen therapy treatment<br>Patients treated only by high flow nasal cannula oxygen therapy | Other: Use of High Flow Nasal Cannula alone<br>* Use of high flow nasal cannula oxygen therapy alone<br>|
| Non-Invasive Ventilation treatment<br>Patients treated by non-invasive ventilation (combined or not with HFNC) | Other: Use of Non-invasive Ventilation<br>* Use of non-invasive ventilation combined or not with high flow nasal cannula oxygen therapy<br>|
| Continuous Positive Airway Pressure treatment<br>Patients treated by continuous positive airway pressure (combined or not with HFNC) | Other: Use of Continuous Positive Airway Pressure<br>* Use of continuous positive airway pressure combined or not with high flow nasal cannula oxygen therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refractory hypoxemia | Rate of refractory hypoxemia outcome defined by invasive Mechanical Ventilation (endotracheal intubation) requirement or death of non-intubated patients because of therapeutical limitation | Through Intensive Care Unit stay, an average of 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical Ventilation free days | Numbers of days without invasive mechanical ventilation during ICU stay and until ICU discharge | Through Intensive Care Unit stay, up to 1 month | 
| Survival at ICU discharge | Rate of patients alive at the moment of intensive care unit discharge | At the moment of Intensive care unit discharge, up to 1 month | 
| ICU length of stay | Number of days spent in Intensive care unit | At the moment of Intensive care unit discharge, up to 1 month | 
| Complications during ICU stay | Number of complications during intensive care unit stay: pneumothorax, pneumomediastinum | Through Intensive Care Unit stay, up to 1 month | 
| Delay between admission and intubation | Period of time (in hours or days) between admission in Intensive Care Unit and intubation requirement with invasive mechanical ventilation. | Through Intensive Care Unit stay, up to 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Novel coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Acute respiratory distress syndrome, High flow nasal canula oxygen, Non-invasive ventilation, Continuous positive airway pressure