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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB | Other Identifier | 2024-A01472-45 |
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In its most severe form, Acute Respiratory Distress Syndrome (ARDS) may require the use of veno-venous ECMO (vvECMO). While the criteria for vvECMO indication, ECMO settings, and ventilator management are relatively well-defined after the publication of the EOLIA trial and subsequent national or international guidelines, few studies have assessed the criteria and methods for weaning from vvECMO. Besides, advances in the understanding of the pathophysiology of mechanical ventilation (MV) weaning process have led to the development of specific monitoring tools for this phase.
Schematically, respiratory drive can be evaluated via the ventilator by measuring the pressure generated during a 100-millisecond expiratory occlusion (P0.1) and respiratory efforts through the measurement of esophageal pressure variation (delta Poeso).
Recent retrospective studies conducted on COVID-19 ARDS patients supported by vvECMO suggest a longer duration of mechanical ventilation for patients whose weaning and decannulation process was "forced," i.e., performed under conditions of significant respiratory drive and effort. High values of P0.1 and delta Poeso were associated with prolonged MV duration. Self-inflicted lung injury (P-SILI) and elevated transpulmonary pressure related to these uncontrolled respiratory efforts likely explain the negative impact on MV duration.
Therefore, this randomized study proposes to assess these monitoring tools, which are regularly used in clinical practice, to guide vvECMO weaning and decannulation decisions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECMO-physio group | Experimental | Patients undergo the ultimate vvECMO weaning test with minimal ECMO support (ECMO flow ≤ 3 L/min, fresh gas flow ≤ 1 L/min, FiO2 21%) and mechanical ventilation with partial support, allowing spontaneous ventilation. P0.1 and delta Poeso values will be monitored and integrated into the decannulation decision |
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| ECMO-gazo group | No Intervention | Patients undergo the ultimate vvECMO weaning test with minimal ECMO support, similar to the experimental group. P0.1 and delta Poeso values will be monitored in a blinded manner by an independent investigator and will not be integrated into the decannulation decision. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P0.1 and delta Poeso integration into the decanulation decision | Other | P0.1 and delta Poeso integration into the decanulation decision |
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| Measure | Description | Time Frame |
|---|---|---|
| Duration of mechanical ventilation from ECMO decannulation to weaning from mechanical ventilation | The weaning from mechanical ventilation is defined as the absence of mechanical ventilation for 48 consecutive hours. | 60 days after inclusion |
| P0.1 and delta Poeso measurements | P0.1 and delta Poeso values will be monitored and tracked at inclusion and then every 8 hours until decannulation, and up to 48 hours after decannulation. In the experimental group, these values will be incorporated into the criteria guiding the decannulation decision. In the control group, these values will be monitored and recorded by an investigator who is not involved in the decannulation decision. These values will not be included in the criteria guiding the decannulation decision. | From inclusion to 48h after decanulation |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate in intensive care unit | 60 days after inclusion | |
| Mortality rate in hospital | 60 days after inclusion | |
| Intensive care unit stay duration from inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sami HRAIECH, M.D., Ph.D | Contact | 04 91 96 58 35 | +33 | sami.hraiech@ap-hm.fr |
| Christophe GUERVILLY, M.D. | Contact | 04 91 96 58 35 | +33 | christophe.guervilly@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| François CREMIEUX | Assistance Publique - Hôpitaux de Marseille | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civiles de Lyon | Recruiting | Lyon | France |
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| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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P0.1 and delta Poeso values will be monitored in a blinded manner by an independent investigator and will not be integrated into the decannulation decision
| 60 days after inclusion |
| Hospital stay duration from inclusion | 60 days after inclusion |
| Total number of days spent on ECMO from admission to intensive care unit discharge | 60 days after inclusion |
| Total duration of mechanical ventilation | 60 days after inclusion |
| Time between the start of mechanical ventilation and ECMO cannulation | 60 days after inclusion |
| Number of ventilator-free days | 60 days after inclusion |
| Number of patients decannulated and then re-initiated on vvECMO | 60 days after inclusion |
| Number of patients requiring controlled ventilation for at least 24 hours after decannulation | 60 days after inclusion |
| Number of days with continuous sedation with or without continuous paralysis after decannulation | 60 days after inclusion |
| Incidence of barotrauma assessed by radiographs and clinical examination after decannulation | 60 days after inclusion |
| Percentage of patients placed in prone positioning after decannulation | 60 days after inclusion |
| Number of days on inhaled nitric oxide after decannulation | 60 days after inclusion |
| Neuromyopathy on the day of decannulation | Neuromyopathy will be assessed using the Medical Research Council score. Total score ranges from 0 (complete tetraplegia) to 60 (normal muscle strength). | Day of decanulation |
| Neuromyopathy on the day of weaning from mechanical ventilation | Neuromyopathy will be assessed using the Medical Research Council score. Total score ranges from 0 (complete tetraplegia) to 60 (normal muscle strength). | Day of weaning from mechanical ventilation |
| Number of patients who received corticosteroid therapy | ≥ 0.5 mg/kg of equivalent methylprednisolone | 60 days after inclusion |
| Assistance - Publique Hôpitaux de Marseille | Recruiting | Marseille | 13005 | France |
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| CHU de Nice | Recruiting | Nice | France |
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| Assistance Publique - Hôpitaux de Paris | Recruiting | Paris | France |
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