Intraoperative hemodynamic management is vital in the success of lung transplantation. Significant intraoperative hemodynamic compromise and hypoxic episodes may contribute to an increase in severe postoperative complications related to hypoperfusion, including cerebrovascular accidents, acute kidney injury, and mesenteric ischemia. In certain lung transplant recipients, intraoperative cardiopulmonary support is mandatory because certain factors would make "off-pump" transplants unsafe. These include severe pulmonary hypertension or severe ventricular dysfunction. In such patients, routine intraoperative support should be employed. However, it is possible to conduct the lung transplant without cardiopulmonary support in the remainder of patients who do not have severe pulmonary hypertension or right heart dysfunction. In such patients, the lung transplant may be started without cardiopulmonary support. However, cardiopulmonary support may be initiated "on-demand" if there is development or impending hemodynamic embarrassment or hypoxia. Conversely, the opposite approach would be to routinely conduct all lung transplant operations using cardiopulmonary support, which may also lead to specific ECMO-related complications. The investigators question whether on demand intraoperative ECMO in patients with significant risk factors will produce severe postoperative complications in a rate similar to routine ECMO.
Hypothesis: In patients where cardiopulmonary bypass (CPB) / ECMO is not mandatory, on-demand use of intra-operative ECMO is equivalent to routine use for patients undergoing lung transplant. The study will be a prospective, randomized controlled trial. The investigators seek to compare outcomes of two different strategies of cardiopulmonary support during lung transplantation; routine support with ECMO versus selective (on-demand), indication- based support with ECMO. The allocation ratio will be 1:1. A multi-center trial is necessary to allow for a sufficient sample size. However, the investigators believe a pilot study is essential to determine feasibility before embarking on such a significant undertaking. In this preliminary pilot study, recruitment will be limited to lung transplant patients at the Centre hospitalier de l'Universite de Montreal (CHUM). The primary purpose of the pilot study will be to define recruitment ability and assess the feasibility of conducting the study. Depending on the results of this pilot study, the next step would be to expand the study to multiple lung transplant centers to achieve an adequate sample size and power, allowing the investigators to answer the question of interest.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
28
Routine ECMO during lung tansplant
Selective, indication-based intraoperative cardiopulmonary support. In this group, the transplant will be planned without cardiopulmonary support. intraoperative ECMO will be used selectively based on hemodynamic and/or gas exchange abnormalities : 1. Inability to maintain adequate hemodynamics and stable perfusion or oxygenation during surgery 2. Prolonged high dose pressor required to maintain adequate perfusion 3. A sustained drop in cerebral saturation \> 25% of baseline despite initial attempts at optimization 4. Inability to tolerate pulmonary artery clamping 5. Inadequate gas exchange despite attempts at the optimization of ventilator parameters and treatments related to respiratory mechanics and ventilation/perfusion matching 6. Inadequate exposure to the surgical field
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Study recruitment rate
Time frame: 6 months after the onset of study
Percentage of patients loss to follow-up
Time frame: 1 year
The composite incidence of death, disabling stroke, grade 2 or 3 primary graft dysfunction at 72 hours, major bleeding (BARC grade 3a, 3b or 5), vascular complications, or stage II or III acute kidney injury at 14 days.
Time frame: 14 days
Incidence of all-cause mortality at 30 days, 90 days, and one year
Time frame: 1 year
Incidence of postoperative stroke / cerebrovascular accident
Time frame: 14 days
Incidence of an Early major postoperative neurologic complication (EMPNC): This includes stroke, severe encephalopathy, and severe seizures diagnosed within 14 days after surgery.
Time frame: 14 days
Incidence of severe postoperative complications. This is defined as Clavien-Dindo grade III complication or greater
Time frame: 14 days
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