Free for Weaning ECMO vs Respiratory Driven Study

Assistance Publique Hopitaux De Marseille50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients aged 18 years or older Patient whose trusted person has given consent for participation in the study * Patient on veno-venous ECMO with weaning criteria, including: * Resolution of the cause of ARDS * Absence of hemodynamic instability, defined as norepinephrine dose ≤ 0.5 μg/kg/min for at least 3 hours * Use of a ventilatory mode that allows spontaneous ventilation (VS-AI, BiPAP, or APRV) * Maximum inspiratory pressure ≤ 28 cm H2O, with a maximum driving pressure ≤ 15 cm H2O, enabling tidal volumes between 4 and 8 ml/kg of predicted body weight (PBW) * ECMO membrane sweep flow ≤ 2 L/min * Patient protected by social security Exclusion Criteria: * Contraindication to the placement of an esophageal pressure balloon (e.g., esophageal varices, nasal trauma, uncontrolled coagulopathy, severe thrombocytopenia), * Patient with treatment limitation at the time of inclusion, * Patient in the time frame of exclusion from another research protocol at the time of consent signing, * Vulnerable patients: minor, adult patient under guardianship or curatorship, patient deprived of liberty, pregnant or breastfeeding woman.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: From inclusion to 48h after decanulation

Secondary Outcomes

Mortality rate in intensive care unit

Time frame: 60 days after inclusion

Mortality rate in hospital

Time frame: 60 days after inclusion

Intensive care unit stay duration from inclusion

Time frame: 60 days after inclusion

Hospital stay duration from inclusion

Time frame: 60 days after inclusion

Total number of days spent on ECMO from admission to intensive care unit discharge

Time frame: 60 days after inclusion

Total duration of mechanical ventilation

Time frame: 60 days after inclusion

Time between the start of mechanical ventilation and ECMO cannulation

Time frame: 60 days after inclusion

Number of ventilator-free days

Time frame: 60 days after inclusion

Number of patients decannulated and then re-initiated on vvECMO

Time frame: 60 days after inclusion

Number of patients requiring controlled ventilation for at least 24 hours after decannulation

Time frame: 60 days after inclusion

Number of days with continuous sedation with or without continuous paralysis after decannulation

Time frame: 60 days after inclusion

Incidence of barotrauma assessed by radiographs and clinical examination after decannulation

Time frame: 60 days after inclusion

Percentage of patients placed in prone positioning after decannulation

Time frame: 60 days after inclusion

Number of days on inhaled nitric oxide after decannulation

Time frame: 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).

Time frame: 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).

Time frame: Day of weaning from mechanical ventilation

Number of patients who received corticosteroid therapy

≥ 0.5 mg/kg of equivalent methylprednisolone

Time frame: 60 days after inclusion

Free for Weaning ECMO vs Respiratory Driven Study

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts