Free for Weaning ECMO vs Respiratory Driven Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique Hopitaux De Marseille
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged 18 years or older Patient whose trusted person has given consent for participation in the study
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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
P0.1 and delta Poeso integration into the decanulation decision
Other interventionP0.1 and delta Poeso integration into the decanulation decision
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: ECMO-physio groupExperimental treatment 1 intervention
Group B: ECMO-gazo groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 inclusion2
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 decanulationSecondary outcomes
1
Mortality rate in intensive care unit
Time frame
60 days after inclusion2
Mortality rate in hospital
Time frame
60 days after inclusion3
Intensive care unit stay duration from inclusion
Time frame
60 days after inclusion4
Hospital stay duration from inclusion
Time frame
60 days after inclusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov