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Decrease of Lesions Induced by Mechanical Ventilation During ARDS (ECMO-VILI)

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Terminated

Conditions

ARDS, Human

Treatments

Other: ventral décubitus

Study type

Interventional

Funder types

Other

Identifiers

NCT03918603
2018-A02297-48 (Registry Identifier)
2018-45

Details and patient eligibility

About

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.

Full 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.

Enrollment

38 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

38 participants in 2 patient groups

ultra-protective multimodal ventilation group
Experimental group
Description:
Patient will be diposed on ventral decubitus: one session at least more than 12 hours between inclusion and H48
Treatment:
Other: ventral décubitus
protective ventilation group
No Intervention group
Description:
Patient will received usual care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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