RecruitingNot ApplicableNCT05547698

A Study of Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation

Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation VIP BOLT Trial: A Multicenter Prospective Randomized Trial

Sponsor

Mayo Clinic

Enrollment

228 participants

Start Date

Sep 17, 2022

Study Type

INTERVENTIONAL

Conditions

Lung Transplant

Summary

The purpose of this research study is to compare the technique of performing bilateral lung transplantation off-pump vs venoarterial ECMO (VA ECMO). The goal of the trial is to determine which technique has lower rates of primary graft dysfunction.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Bilateral Lung Transplantation (LTx) recipients.
Mean pulmonary artery pressure < or = 35 mmHg.
Eligible for off-pump or VA ECMO based on the judgement of the attending surgeon.

Exclusion Criteria8

Single lung transplant
Multiorgan transplant.
Donor after cardiac death (DCD).
Re-transplant.
Intention to use prophylactic post-operative ECMO.
Previous major lung surgery. Video-assisted thoracoscopic surgery (VATS) and wedge resection are not an exclusion criterion.
Previous pleurodesis.
Preoperative ECMO and/or mechanical ventilation.

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Interventions

PROCEDUREOff-pump lung transplantation

General anesthesia, intubation with double lumen tube, thoracotomies or clamshell incision, pneumonectomy starting by the less perfused lung in the scan, stump preparation, lung implantation, reperfusion, gradual release of the pulmonary artery clamp, deairing, ventilation of the 1st implanted lung. The process is repeated at the contralateral side. Ventilation of both lungs, chest closure.

PROCEDUREVenoarterial ECMO lung transplantation

General anesthesia, intubation with double lumen tube, thoracotomies or clamshell incision, heparin, peripheral or central venoarterial ECMO cannulation, first pneumonectomy, stump preparation, lung implantation, reperfusion, release of the pulmonary artery clamp, deairing, ventilation of the 1st implanted lung. The process is repeated at the contralateral side. Ventilation of both lungs, ECMO decannulation, chest closure.