Department of Rehabilitation Medicine, the First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, Nanjing, 210029, China.
Department of Rehabilitation Medicine, Qingdao Hospital, University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital), Qingdao, China.
BMC Pulm Med. 2024 Oct 14;24(1):512. doi: 10.1186/s12890-024-03286-1.
Coronary artery bypass grafting is associated with a high occurrence of postoperative cardiopulmonary complications. Preliminary evidence suggested that enhanced recovery after surgery can effectively reduce the occurrence of postoperative cardiopulmonary complications. However, enhanced recovery after surgery with systematic integration of cardiopulmonary rehabilitation (ERAS-CaRe) into for Coronary artery bypass grafting has not been evaluated so far. We thus design the ERAS-CaRe randomized-controlled trial to evaluate possible superiority of embedding cardiopulmonary rehabilitation in ERAS over ERAS alone as well as to investigate effects of differential timing of cardiopulmonary rehabilitation within enhanced recovery after surgery (pre-, post-, perio-operative) on post-operative cardiopulmonary complications following Coronary artery bypass grafting surgery.
ERAS-CaRe is a pragmatic, randomized-controlled, parallel four-arm, clinical trial. Three hundred sixty patients scheduled for Coronary artery bypass grafting in two Chinese hospitals will be grouped randomly into (i) Standard enhanced recovery after surgery or (ii) pre-operative ERAS-CaRe or (iii) post-operative ERAS-CaRe or (iv) perio-operative ERAS-CaRe. Primary outcome is the occurrence of cardiopulmonary complications at 10 days after Coronary artery bypass grafting. Secondary outcomes include the occurrence of other individual complications including cardiac, pulmonary, stroke, acute kidney injury, gastrointestinal event, ICU delirium rate, reintubation rate, early drainage tube removal rate, unplanned revascularization rate, all-cause mortality, ICU readmission rate, plasma concentration of myocardial infarction-related key biomarkers etc. DISCUSSION: The trial is designed to evaluate the hypothesis that a cardiopulmonary rehabilitation based enhanced recovery after surgery program reduces the occurrence of cardiopulmonary complications following Coronary artery bypass grafting and to determine optimal timing of cardiopulmonary rehabilitation within enhanced recovery after surgery. The project will contribute to increasing the currently limited knowledge base in the field as well as devising clinical recommendations.
The trial was registered at the Chinese Clinical Trials Registry on 25 August 2023 (ChiCTR2300075125; date recorded: 25/8/2023, https://www.chictr.org.cn/ ).
冠状动脉旁路移植术术后心肺并发症发生率较高。初步证据表明，术后加速康复（ERAS）可有效降低术后心肺并发症的发生。然而，将心肺康复系统地整合到冠状动脉旁路移植术（CABG）中的 ERAS-CaRe 尚未得到评估。因此，我们设计了 ERAS-CaRe 随机对照试验，以评估将心肺康复纳入 ERAS 与单纯 ERAS 相比的优越性，以及研究在 CABG 术后 ERAS 中不同时间点（术前、术后、围手术期）进行心肺康复对术后心肺并发症的影响。
ERAS-CaRe 是一项实用的、随机对照的、平行四臂临床试验。将在中国两家医院接受 CABG 治疗的 360 名患者随机分为（i）标准 ERAS 或（ii）术前 ERAS-CaRe 或（iii）术后 ERAS-CaRe 或（iv）围手术期 ERAS-CaRe。主要结局是 CABG 术后 10 天心肺并发症的发生情况。次要结局包括其他单个并发症的发生情况，包括心脏、肺部、中风、急性肾损伤、胃肠道事件、ICU 谵妄发生率、再插管率、早期引流管拔除率、计划性血运重建率、全因死亡率、ICU 再入院率、心肌梗死相关关键生物标志物的血浆浓度等。
该试验旨在评估基于心肺康复的 ERAS 方案可降低 CABG 术后心肺并发症发生率的假设，并确定 ERAS 中心肺康复的最佳时机。该项目将有助于增加该领域有限的现有知识库，并制定临床建议。
该试验于 2023 年 8 月 25 日在中国临床试验注册中心注册（ChiCTR2300075125；记录日期：2023 年 8 月 25 日，https://www.chictr.org.cn/ ）。
