RecruitingNot ApplicableNCT05664204

Veno-arterial ExtraCorporeal Membrane Oxygenation to Reduce Morbidity and Mortality Following Lung TransPlant

Veno-arterial Extracorporeal Membrane Oxygenation to Reduce Morbidity and Mortality Following Lung Transplant: a Randomized Controlled Trial

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

200 participants

Start Date

Feb 29, 2024

Study Type

INTERVENTIONAL

Conditions

The Number of Ventilator-free Days in the 28 Days Following LT

Summary

In patients undergoing lung transplantation (LT), the investigators hypothesize that a "systematic" intraoperative ECMO strategy would reduce the need for invasive mechanical ventilation in the first 28 days without increasing adverse events, as compared to an "on-demand" intraoperative ECMO strategy. To date, LT remains a highly hazardous procedure. Even if the surgical procedure is well established, the intraoperative support is not, and most intra-operative ECMO decisions rely on local protocols, anesthesiologists' habits, and surgeons' preference. The efficacy of applying a "systematic" strategy on reducing the occurrence of severe primary graft dysfunction and thus mechanical ventilation in the 28 days following LT, without increasing mortality or morbidity, would support future guidelines on the use of ECMO in the intraoperative period of LT for obstructive and restrictive lung diseases.

Eligibility

Min Age: 18 Years

Inclusion Criteria1

Age \>18 years Assessed for bilateral sequential lung transplantation for obstructive or restrictive lung disease Affiliation to the French social security Written informed consent

Exclusion Criteria15

At listing :
a pulmonary hypertension with a mPAP \> 45 mmHg, including in the absence of haemodynamic collapse (MAP, LVEF, RV function all normal)
a pulmonary hypertension with echocardiographic evidences of right heart dysfunction (paradoxical septum or RV dilatation or RVEF \< 35%)
a pre-capillary pulmonary hypertension at right heart catheterization with low cardiac output
LT for primary pulmonary hypertension
LT for cystic fibrosis and graft-vs-host disease
Re-do LT
Combined multi-organ transplantation
Active malignancy
Pregnancy, breastfeeding
Patients under guardianship (tutelle, curatelle, sauvegarde de justice)
Patients without pulmonary hypertension or with pulmonary hypertension without right ventricular dilatation on an echocardiography in the last 6 months will be randomized; Patients meeting one of the following criteria will not be randomized and will be secondary excluded from the study :
preoperative severe pulmonary hypertension with hemodynamic collapse on echocardiography defined by: paradoxical septum or dilatation of the right ventricle or RVEF \< 20LT in a patient under ECMO as bridge-to-transplantation
PreLT hypoxemia with PaO2/FiO2 \< 80mmHg
PreLT hypercapnia PaCO2 \> 80 mmHg after induction

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Interventions

PROCEDUREVeno-arterial extracorporeal membrane oxygenation

Strategy would reduce the need for invasive mechanical ventilation in the first 28 days without increasing adverse events

Locations(2)

Hôpital Bichat Claude Bernard

Paris, France

Hôpital FOCH

Suresnes, France

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NCT05664204