Routine Versus Selective Intraoperative ECMO in Lung Transplant (NCT05505422) | Clinical Trial Compass
CompletedNot Applicable
Routine Versus Selective Intraoperative ECMO in Lung Transplant
Canada28 participantsStarted 2022-09-15
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Inability to provide consent for the study or patient refusal
. Retransplantation
. Multi-organ transplantation
. Lung transplant recipients where intraoperative support is mandatory and "off- pump" transplant would be unsafe:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial comparing routine versus selective use of ECMO during lung transplant surgery has already completed — does that mean results are available, and if so, how do the two approaches compare in terms of complications?
2Since this study was primarily measuring recruitment rate rather than patient outcomes like survival or recovery, what do we actually know so far about whether routine ECMO during lung transplant is safer or better than using it only when needed?
3ECMO during surgery carries its own risks like bleeding and vascular complications — can you help me understand how those risks differ depending on whether ECMO is used routinely or only selectively in cases like mine?
4Given that this trial is completed but was designed as a feasibility study, is there a larger follow-up trial planned that might give stronger evidence on which ECMO approach leads to better outcomes after lung transplant?
5Based on what this trial and other research show, which approach to ECMO support during lung transplant surgery would you recommend for my specific situation, and why?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Study recruitment rate
Timeframe: 6 months after the onset of study
Trial details
NCT IDNCT05505422
SponsorCentre hospitalier de l'Université de Montréal (CHUM)