Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2026-01-01 @ 1:21 PM
Study NCT ID:
NCT03918603
Status:
TERMINATED
Last Update Posted:
2023-07-20
First Post:
2019-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decrease of Lesions Induced by Mechanical Ventilation During ARDS
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Study Overview
Official Title:
Reduction of Mechanical Ventilation-induced Lesions During ARDS With Multimodal Ultra-protective Ventilation in Combination With ECMO
Status:
TERMINATED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
mid-term analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECMO-VILI
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2018-A02297-48 | REGISTRY | APHM | View |