Routine vs On-demand ECMO for Lung Transplantation
RoutinE Versus On-demand Intraoperative Extracorporeal Membrane Oxygenation (ECMO) During LUng TransplantatION (REVOLUTION)
Centre hospitalier de l'Université de Montréal (CHUM)
218 participants
Nov 5, 2024
INTERVENTIONAL
Conditions
Summary
Lung transplantation is a complex procedure performed in patients with terminal lung disease. The transplant procedure stresses the patient's heart and lungs, which are already taxed by the underlying disease process. The heart-lung machine is occasionally used to support the patient and ensure adequate oxygen supply to other organs during the operation. It can be used routinely in all patients or selectively in patients who exhibit reduced oxygen supply to the remaining organs. This process, known as cardiopulmonary bypass (CPB), pumps blood out of the body to a heart-lung machine that removes carbon dioxide and returns oxygen-filled blood to the body. Although using the CPB increases the risk of bleeding, infection, and coagulation complications, it should still be considered in high-risk patients to compensate for more severe complications such as kidney failure and stroke caused by a lack of cardiopulmonary support. Extracorporeal membrane oxygenation (ECMO) is a recently developed CPB variation associated with fewer bleeding complications. It has recently replaced the traditional heart-lung machine as the preferred method of cardiopulmonary support during lung transplantation. Since ECMO is associated with fewer complications than standard CPB, many centers have increased their use of ECMO during lung transplantation. Some have even employed it routinely. However, there remains significant debate on how often it should be used. Therefore, the study's main objective is to compare the two approaches in lung transplantation, i.e., routine use versus selective use, and to determine if one approach is preferable to the other.
Eligibility
Inclusion Criteria1
- Patients undergoing lung transplant surgery
Exclusion Criteria12
- Inability to provide consent for the study
- Retransplantation
- Multi-organ transplantation
- Contra-indication to standard heparin anticoagulation (e.g., heparin-induced thrombocytopenia)
- Lung transplant recipients where intraoperative cardiopulmonary support is mandatory:
- Severe pulmonary hypertension (PH):
- Systolic pulmonary artery pressure (PAP) ≥ 80 mm Hg on the most recent echocardiography, right heart catheterization, or pulmonary artery catheter measurement
- Mean PAP ≥ 55 mm Hg on the most recent echocardiography, right heart catheterization, or pulmonary artery catheter measurement
- The ratio of mean pulmonary to systemic artery pressure of \> 0.66
- Moderate to severe right ventricular (RV) hypokinesis or dysfunction
- Left ventricular dysfunction: Defined as ejection fraction (LVEF) less than 45% on echocardiography, ventriculography, computed tomography (CT), or magnetic resonance imaging (MRI)
- Patients requiring concomitant cardiac surgery: For example, significant coronary artery disease (CAD) requiring surgical grafting
Interventions
Routine intraoperative venoarterial ECMO during lung transplant
Selective, indication-based intraoperative cardiopulmonary support. In this group, the transplant will be planned without cardiopulmonary support. intraoperative venoarterial ECMO will be used selectively based on hemodynamic and/or gas exchange abnormalities : 1. Inability to maintain adequate hemodynamics and stable perfusion despite volume resuscitation and vasopressor administration and in the absence of readily correctable cause 2. Inability to tolerate pulmonary artery clamping 3. Inadequate gas exchange despite attempts at the optimization of ventilator parameters and treatments related to respiratory mechanics and ventilation/perfusion matching 4. Inadequate exposure to the surgical field 5. The transplant team is concerned about the ability to maintain organ perfusion or ventilate with a lung protective strategy, even if the aforementioned criteria are unmet. 6. Concerns about donor lung quality and a desire to protect the implanted lung from single lung perfusion
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06615492