Interleukine 6 (IL6) Assay for Predicting Failure of Spontaneous Breathing in Patients With COVID-19 Acute Respiratory Distress Syndrome

Study Overview
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Brief Summary
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In the current COVID-19 pandemic, many patients have an acute respiratory distress syndrome (ARDS). Among mechanisms related to COVID-19 acute respiratory distress syndrome, cytokine storm and secretion of IL-6 play a central role. ARDS management involves intubation for protective mechanical ventilation, deep sedation and curarisation. During intensive care unit (ICU) hospitalization, improvement of hematosis induces a switch from a controlled ventilation mode to a withdrawal ventilation mode, such as Spontaneous Ventilation with Pressure Support (SP-PS) or Adaptative Support Ventilation (ASV). This step is essential prior to considering complete weaning from controlled ventilation and sometimes ends with a failure. In this case, deterioration of hematosis and/or ventilatory mechanics is observed. At the same time as withdrawal failure, the investigators observed biological inflammatory rebound in some patients. Therefore, influence of inflammatory biological parameters, including IL-6, on withdrawal failure, needs to be investigated. To this end, the investigators decide to dose different inflammatory markers - such as IL6, C-Reactive Protein (CRP), Procalcitonin (PCT) - in patients with acute respiratory distress syndrome due to COVID-19, during standard of care. Indeed, in patients with acute respiratory distress syndrome not due to COVID-19, the increase in IL6 is a negative prognosis during medical first aid but also when the mechanical ventilation is withdrawn. In addition, IL6 rise is associated with poor prognosis for patients with COVID-19 and longer stays in intensive care.

Official Title
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Interleukine 6 (IL6) Assay for Predicting Failure of Spontaneous Breathing in Patients With COVID-19 Acute Respiratory Distress Syndrome

Conditions
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COVID-19 Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Biological: IL6 assessment
* Biological: CRP and PCT assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>18 years Patients with COVID-19 (positive COVID PCR) Use of intubation for mechanical ventilation Exclusion Criteria: Use of Extracorporeal Membrane Oxygenation Treatment with Tocilizumab (anti-Il6) Pregnant woman Patients under protective administration or deprived of liberty

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with COVID-19 acute respiratory distress syndrome<br>Patients with acute respiratory distress syndrome due to COVID-19 and requiring mechanical ventilation | Biological: IL6 assessment<br>* Blood IL6 will be assessed during trial<br>Biological: CRP and PCT assessment<br>* Blood CRP and PCT will be assessed during trial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentration of IL6 | Change of blood IL6 concentration during switch from a controlled ventilation mode to a weaning ventilation mode in COVID-19 patients | Up to 72 hours after the start of respiratory weaning | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentration of CRP and PCT | Change of blood CRP et PCT concentration during switch from a controlled ventilation mode to a weaning mode in COVID-19 patients | Up to 48 hours after the start of respiratory weaning | 
| Pulmonary wedge pressure | Change of pulmonary wedge pressure (in mmHg), respiratory rate (in breaths per minute), Fraction of inspired oxygen (FiO2, in percentage), Tidal Volume (in ml/kg) during switch from a controlled ventilation mode to a weaning mode in COVID-19 patients | Up to 48 hours after the start of respiratory weaning | 
| Respiratory rate | Change of respiratory rate (in breaths per minute) during switch from a controlled ventilation mode to a weaning mode in COVID-19 patients | Up to 48 hours after the start of respiratory weaning | 
| Fraction of inspired oxygen | Change of Fraction of inspired oxygen (FiO2, in percentage) during switch from a controlled ventilation mode to a weaning mode in COVID-19 patients | Up to 48 hours after the start of respiratory weaning | 
| Tidal Volume | Change of Tidal Volume (in ml/kg) during switch from a controlled ventilation mode to a weaning mode in COVID-19 patients | Up to 48 hours after the start of respiratory weaning | 
| Days of mechanical ventilation | Duration of mechanical ventilation (days) | At the start of respiratory weaning | 
| Number of ventral decubitus | Number of ventral decubitus during mechanical ventilation mode | At the start of respiratory weaning | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interleukin-6, Acute Respiratory Distress Syndrome, COVID-19