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Decrease of Lesions Induced by Mechanical Ventilation During ARDS

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03918603
Acronym
ECMO-VILI
Enrollment
38
Registered
2019-04-17
Start date
2019-07-03
Completion date
2021-06-23
Last updated
2023-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, Human

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.

Interventions

OTHERventral décubitus

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

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
inflammation of biotrauma36monthsInterleukine dosage in pg/mL

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026