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

Hospices Civils de Lyon37 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Respiratory Distress Syndrome

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in driving pressure

Driving pressure is the difference between total respiratory system plateau pressure minus total positive end-expiratory pressure (PEEP)

Time frame: Baseline and 24 hours following inclusion

Secondary Outcomes

Rate of patients who achieved tidal volume reduction equal to 4 ml/kg predicted body weight

Time frame: 48 hours following inclusion

Rate of pneumothorax

Time frame: Day 90

Change in right ventricule/left ventricule area

Echographic measurement of right ventricule/left ventricule