Prone Positioning and R/I Ratio in COVID-19 Patients With ARDS (SyDRAC-DV)

Study Overview
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Brief Summary
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The purpose of this study is to determine the efects of prone positioning on the recruitment- to-inflation ratio in COVID-19 patients with acute respiratory distress syndrome.

Detailed Description
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High positive end-expiratory pressure (PEEP) level and prone positioning (PP) are recommended in patients with moderate to severe acute respiratory distress syndrome (ARDS) in order to recruit lung and thus to improve oxygenation. Thus, high PEEP level and prone positioning will be more effective in patients with high potential for lung recruitment. Recently, the Recruitment-to-Inflation Ratio (R/I ratio) has been described and validated in patients with ARDS to estimate the potential for lung recruitment. In this regard, the R/I ration may be of interest to titrate PEEP level in patients with ARDS. This would be of particular interest in COVID-19 patients with ARDS, since different ARDS phenotypes with heterogeneous potential of lung recruitment have been described in these patients. However, the effects of prone positioning on R/I ratio have been scarcely described so far. Thus, the main goal of this study is to investigate the effects of prone positioning on the R/I ratio in COVID-19 patients with ARDS. The second goal of this study is to determine the effects of prone positioning on oxygenation and respiratory mechanics according to the R/I ratio.

Official Title
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Effects of Prone Positioning-induced on the Recruitment-to-inflation Ratio in COVID-19 Patients With Acute Respiratory Distress Syndrome

Conditions
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COVID-19 Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Procedure: Prone positioning session


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Invasive mechanical ventilation Patients with acute respiratory distress syndrome according to the Berlin definition Positive COVID-19 real-time reverse transcriptase-polymerase chain reaction assay in nasal swabs or pulmonary samples. Indication to a prone positioning session by the attending physician Exclusion Criteria: Age <18 years and pregnant women Patients under legal protection Acute core pulmonale Pneumothorax and/or chest drainage Hemodynamic failure Increase in norepinephrine dosage >30% within the last 6 hours Norepinephrine dosage > 0.5 mg/kg/min

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 |
| --- | --- |
| Prone positioning session<br> | Procedure: Prone positioning session<br>* To perform respiratory measurements before, during and after a prone positioning session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prone positioning-induced decrease in R/I ratio. | The R/I ratio will be calculated before (within 30 minutes before), during (2h, 8h and 16h) and after (2h and 4h after) a prone positioning session. | 16-hour prone positioning session and 4-hour period after supine repositioning | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients responders to prone positioning session | The R/I ratio will be calculated before (within 30 minutes before), during (2h, 8h and 16h) and after (2h and 4h after) a prone positioning session. | 16-hour prone positioning session and 4-hour period after supine repositioning | 
| Clinical and respiratory predictors of prone positioning response in terms of oxygenation | TROC curves of clinical and biological variables for prediction of response to prone positioning | 16-hour prone positioning session and 4-hour period after supine repositioning | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARDS, COVID-19, Prone positioning, Lung recruitement