Monitoring of Occlusion Pressure and Esophageal Pressure to Guide Weaning From Venovenous ECMO in ARDS: a Randomized Controlled Study

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hospices Civiles de Lyon
RECRUITING
Lyon
Assistance - Publique Hôpitaux de Marseille
RECRUITING
Marseille
CHU de Nice
RECRUITING
Nice
Assistance Publique - Hôpitaux de Paris
RECRUITING
Paris
Contact Information
Primary
Sami HRAIECH, M.D., Ph.D
sami.hraiech@ap-hm.fr
04 91 96 58 35
Backup
Christophe GUERVILLY, M.D.
christophe.guervilly@ap-hm.fr
04 91 96 58 35
Time Frame
Start Date: 2025-07-29
Estimated Completion Date: 2027-09
Participants
Target number of participants: 50
Treatments
Experimental: ECMO-physio group
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
No_intervention: ECMO-gazo group
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.
Sponsors
Leads: Assistance Publique Hopitaux De Marseille

This content was sourced from clinicaltrials.gov