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

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ClinicalTrials.gov Identifier: NCT03918603
Recruitment Status : Not yet recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
ARDS, Human Other: ventral décubitus Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Reduction of Mechanical Ventilation-induced Lesions During ARDS With Multimodal Ultra-protective Ventilation in Combination With ECMO
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Experimental: ultra-protective multimodal ventilation group
Patient will be diposed on ventral decubitus: one session at least more than 12 hours between inclusion and H48
Other: ventral décubitus
Patient will have one session at least more than 12 hours between inclusion and H48 of ventral décubitus

No Intervention: protective ventilation group
Patient will received usual care



Primary Outcome Measures :
  1. inflammation of biotrauma [ Time Frame: 36months ]
    Interleukine dosage in pg/mL



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918603


Contacts
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Contact: Christophe Guervilly 04 91 96 58 42 christophe.guervilly@ap-hm.fr
Contact: Patrick Sudour 04 91 38 29 03 promotion.interne@ap-hm.fr

Locations
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France
Assistance Publique Hopitaux de Marseille Not yet recruiting
Marseille, France, 13354
Contact: Christophe Guervilly    04 91 96 58 42 ext +33    christophe.guervilly@ap-hm.fr   
Contact: Patrick Sudour    04 91 38 29 03 ext +33    patrick.sudour@ap-hm.fr   
Sub-Investigator: Laurent Papazian         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Emilie GARRIDO Assistance Publique Hôpitaux de Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03918603     History of Changes
Other Study ID Numbers: 2018-45
2018-A02297-48 ( Registry Identifier: APHM )
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders