Decrease of Lesions Induced by Mechanical Ventilation During ARDS

Not Applicable

Terminated

• Conditions: ARDS, Human
• Interventions: Other: ventral décubitus

• Registration Number: NCT03918603
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

Modification of mechanically ventilated lesions by an ultra-protective multimodal strategy compared to a protective strategy in patients with veno-venous ECMO for severe ARDS.

Detailed Description

the hypothesis is that ECMO, in addition to improving gas exchange, should limit the deleterious effects of mechanical ventilation (mechanical ventilation-induced lesions, VILI) by drastically reducing minute ventilation (volume reduction). current, Vt, reduction of respiratory rate, reduction of mechanical power, reduction of motor pressure or driving pressure), adapting the level of PEEP from the data collected by monitoring oesophageal pressure and systematically performing positioning sessions in the prone position. This ultra-protective strategy could thus promote the restoration of the integrity of the alveolo-capillary membrane and thus facilitate the healing of patients. In order to verify this concept and, if necessary, to propose a study whose objectives would be more clinical (mortality, ventilator-free days), we propose to carry out a study aimed at showing that this ultra-protective multimodal strategy reduces the lesions induced by mechanical ventilation compared to usual protective ventilatory management during the ECMO as proposed in the EOLIA study.

Study Timeline

• Study First Submitted: 2019-04-12
• Study First Submitted QC: 2019-04-16
• Study First Posted: 2019-04-17
• Study Start: 2019-07-03
• Primary Completion: 2021-04-23
• Study Completion: 2021-06-23
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• severe ARDS with a PaO2 / FiO2 ratio ≤ 70 mmHg (for at least 2h) measured at PEEP> 10 cmH2O and FiO2 = 1
• OR a severe ARDS with a PaO2 / FiO2> 70 ratio but <100 mmHg with a plateau pressure> 35 cmH2O and a pH <7.20

Exclusion Criteria

• Patients with associated hemodynamic failure requiring veno-arterial ECMO
• Impossibility of setting up or contraindication to the placement of an esophageal tube
• Impossibility of realization of ventral decubitus
• Patient to receive corticosteroids during the first 48 hours following venous venous ECMO.
• Patients assisted by veno-venous ECMO for more than 24 hours.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ultra-protective multimodal ventilation group	ventral décubitus	Patient will be diposed on ventral decubitus: one session at least more than 12 hours between inclusion and H48

Primary Outcome Measures

Name	Time	Method
inflammation of biotrauma	36months	Interleukine dosage in pg/mL

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France