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

Civil Hospices of Lyon

Status: Completed

Conditions: Acute Respiratory Distress Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02816372

69HCL16_0082

2016-A00503-48 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Tidal volume 4 ml/kg Predicted Body Weight (PBW)

Experimental group

Treatment:

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