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Randomized Trial Of Routine Versus On-demand Intraoperative Extracorporeal Membrane Oxygenation In Lung Transplantation: A Feasibility Study
The Journal of Heart and Lung Transplantation ( IF 8.9 ) Pub Date : 2024-02-28 , DOI: 10.1016/j.healun.2024.02.1454
Basil S. Nasir , Jason Weatherald , Tim Ramsay , Marcelo Cypel , Laura Donahoe , Chris Durkin , Travis Schisler , Jayan Nagendran , Moishe Liberman , Caroline Landry , Charles Overbeek , Alex Moore , Pasquale Ferraro

In most centers, extracorporeal membrane oxygenation (ECMO) is the preferred means to provide cardiopulmonary support during lung transplantation. However, there is controversy about whether intraoperative venoarterial (VA) ECMO should be used routinely or selectively. A randomized controlled trial is the best way to address this controversy. In this publication, we describe a feasibility study to assess the practicality of a protocol comparing routine versus selective VA ECMO during lung transplantation. This prospective, single-center, randomized controlled trial screened all patients undergoing lung transplantation. Exclusion criteria include retransplantation, multi-organ transplantation, and cases where ECMO is mandatory. We determined that the trial would be feasible if we could recruit 19 participants over six months with less than 10% protocol violations. Based on the completed feasibility study, we conclude that the protocol is feasible and safe, giving us the impetus to pursue a multicenter trial with little risk of failure due to low recruitment.

中文翻译:

肺移植中常规与按需术中体外膜氧合的随机试验:可行性研究

在大多数中心,体外膜肺氧合(ECMO)是肺移植期间提供心肺支持的首选方式。然而,术中静脉动脉(VA)ECMO是常规使用还是选择性使用尚存在争议。随机对照试验是解决这一争议的最佳方法。在本出版物中,我们描述了一项可行性研究,以评估肺移植过程中常规与选择性 VA ECMO 比较方案的实用性。这项前瞻性、单中心、随机对照试验筛选了所有接受肺移植的患者。排除标准包括再移植、多器官移植以及强制使用 ECMO 的病例。我们确定,如果我们能够在六个月内招募 19 名参与者,且违反方案的情况少于 10%,则该试验是可行的。根据已完成的可行性研究,我们得出结论,该方案是可行且安全的,这给了我们动力去进行多中心试验,并且由于招募量少而失败的风险很小。
更新日期:2024-02-28
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