Decrease of Lesions Induced by Mechanical Ventilation During ARDS

NCT ID: NCT03918603

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-03
• Study Completion Date: 2021-06-23

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.

Conditions

ARDS, Human

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

ultra-protective multimodal ventilation group

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

Group Type: EXPERIMENTAL

ventral décubitus

Intervention Type: OTHER

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

protective ventilation group

Patient will received usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ventral décubitus

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emilie GARRIDO

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

References

Guervilly C, Fournier T, Chommeloux J, Arnaud L, Pinglis C, Baumstarck K, Boucekine M, Valera S, Sanz C, Adda M, Bobot M, Daviet F, Gragueb-Chatti I, Forel JM, Roch A, Hraiech S, Dignat-George F, Schmidt M, Lacroix R, Papazian L. Ultra-lung-protective ventilation and biotrauma in severe ARDS patients on veno-venous extracorporeal membrane oxygenation: a randomized controlled study. Crit Care. 2022 Dec 12;26(1):383. doi: 10.1186/s13054-022-04272-x.

Reference Type: DERIVED

PMID: 36510324 (View on PubMed)

Other Identifiers

2018-A02297-48

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-45

Identifier Type: -

Identifier Source: org_study_id