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

Primary Purpose

ARDS, Human

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ventral décubitus
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for ARDS, Human

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ultra-protective multimodal ventilation group

protective ventilation group

Arm Description

Patient will be diposed on ventral decubitus: one session at least more than 12 hours between inclusion and H48

Patient will received usual care

Outcomes

Primary Outcome Measures

inflammation of biotrauma
Interleukine dosage in pg/mL

Secondary Outcome Measures

Full Information

First Posted
April 12, 2019
Last Updated
July 19, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT03918603
Brief Title
Decrease of Lesions Induced by Mechanical Ventilation During ARDS
Acronym
ECMO-VILI
Official Title
Reduction of Mechanical Ventilation-induced Lesions During ARDS With Multimodal Ultra-protective Ventilation in Combination With ECMO
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
mid-term analysis
Study Start Date
July 3, 2019 (Actual)
Primary Completion Date
April 23, 2021 (Actual)
Study Completion Date
June 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, Human

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ultra-protective multimodal ventilation group
Arm Type
Experimental
Arm Description
Patient will be diposed on ventral decubitus: one session at least more than 12 hours between inclusion and H48
Arm Title
protective ventilation group
Arm Type
No Intervention
Arm Description
Patient will received usual care
Intervention Type
Other
Intervention Name(s)
ventral décubitus
Intervention Description
Patient will have one session at least more than 12 hours between inclusion and H48 of ventral décubitus
Primary Outcome Measure Information:
Title
inflammation of biotrauma
Description
Interleukine dosage in pg/mL
Time Frame
36months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie GARRIDO
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

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Decrease of Lesions Induced by Mechanical Ventilation During ARDS

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