Decrease of Lesions Induced by Mechanical Ventilation During ARDS

ARDS, Human Clinical Trial

— ECMO-VILI  

Official title:

Reduction of Mechanical Ventilation-induced Lesions During ARDS With Multimodal Ultra-protective Ventilation in Combination With ECMO

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03918603
• Other study ID #: 2018-45
• Secondary ID: 2018-A02297-48
• Status: Terminated
• Phase: N/A
• Start date: July 3, 2019
• Est. completion date: June 23, 2021

Study information

• Verified date: July 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: June 23, 2021
• Est. primary completion date: April 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• ARDS, Human
• Respiratory Distress Syndrome

Intervention

Other:
• ventral décubitus
Patient will have one session at least more than 12 hours between inclusion and H48 of ventral décubitus

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammation of biotrauma	Interleukine dosage in pg/mL	36months