Acute Respiratory Distress Syndrome
Conditions
Brief summary
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
Interventions
OTHERTidal volume reduction to 4 ml/kg Predicted Body Weight (PBW)
Tidal volume reduction to 4 ml/kg predicted body weight from inclusion to weaning PEEP trial
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in driving pressure | Baseline and 24 hours following inclusion | Driving pressure is the difference between total respiratory system plateau pressure minus total positive end-expiratory pressure (PEEP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline and 24 hours following inclusion | Echographic measurement of right ventricule/left ventricule |
Countries
France
Outcome results
None listed