Ultra Protective Ventilation Without Extracorporeal Circulation in Severe ARDS Patients (VT4ARDS)

Study Overview
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Brief Summary
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Despite the use of protective ventilation, neuromuscular blocking agent and prone position, ARDS mortality remains high (30%-50%) in observational studies, and pneumothorax rate in randomized controlled trial remains stable (10%). The driving pressure (the ratio of tidal volume over respiratory system compliance) has recently been strongly associated with ARDS mortality, suggesting that tidal volume reduction below 6ml/kg may offer mortality benefit. While extracorporeal CO2 removal technique are currently under investigation in association with tidal volume reduction

Official Title
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Ultra Protective Ventilation Without Extracorporeal Circulation in Severe ARDS Patients (VT4ARDS)

Conditions
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Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Other: Tidal volume reduction to 4 ml/kg Predicted Body Weight (PBW)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: invasive mechanical ventilation ARDS (Berlin definition) with PaO2/FiO2 ratio ≤ 150 mm Hg Exclusion Criteria: Age below 18 year planned duration of invasive mechanical ventilation < 48 hours ARDS criteria present for more than 24 hours known or suspected intracranial hypertension known or suspected COPD chronic respiratory failure under long term oxygen or non-invasive ventilation pneumothorax or broncho-pleural fistula morbid obesity with body weight >1 kg/cm height sickle cell disease recent bone marrow transplantation, aplasia following chemotherapy burn injury on more than 30% of body surface severe hepatic cirrhosis (Child-Pugh score C) extracorporeal circulation life support pregnancy advance directives to withhold or withdraw life-sustaining treatment previous inclusion in present study patient under an exclusion period following inclusion in another biomedical study patient deprived of freedom, minor, subject under a legal protective measure lack of affiliation to social security as required by French regulation lack of written informed consent by patient or next of kin

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tidal volume 4 ml/kg Predicted Body Weight (PBW)<br> | Other: Tidal volume reduction to 4 ml/kg Predicted Body Weight (PBW)<br>* Tidal volume reduction to 4 ml/kg predicted body weight from inclusion to weaning PEEP trial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in driving pressure | Driving pressure is the difference between total respiratory system plateau pressure minus total positive end-expiratory pressure (PEEP) | Baseline and 24 hours following inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients who achieved tidal volume reduction equal to 4 ml/kg predicted body weight |  | 48 hours following inclusion | 
| Rate of pneumothorax |  | Day 90 | 
| Change in right ventricule/left ventricule area | Echographic measurement of right ventricule/left ventricule | Baseline and 24 hours following inclusion |