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心脏手术患者术后康复路径:一项随机临床试验。

Enhanced recovery after surgery pathway for patients undergoing cardiac surgery: a randomized clinical trial.

机构信息

Department of Anaesthesiology, Xiangya Hospital, Central South University, Changsha, Hunan, China.

Department of Anesthesiology, Stony Brook University, Stony Brook, NY, USA.

出版信息

Eur J Cardiothorac Surg. 2018 Sep 1;54(3):491-497. doi: 10.1093/ejcts/ezy100.

Abstract

OBJECTIVES

Enhanced recovery after surgery (ERAS) pathways have not been reported in cardiac surgery. The aim of this study was to evaluate the clinical effectiveness and safety profile of ERAS pathways compared with routine care for patients undergoing cardiac valvular surgery.

METHODS

A randomized clinical trial was conducted between July 2015 and November 2016. A total of 226 patients who underwent elective valvular surgery were randomly assigned to the ERAS pathway or routine care (control) group. The ERAS protocol consisted of an evidence-based systematic optimization approach for managing perioperative patients. The control group received routine care. The primary end-point was readiness for hospital discharge. The secondary outcomes were duration of intensive care unit (ICU) stay, length of postoperative vasoactive drug support, duration of mechanical ventilation, time to first bowel movement, removal of surgical drain, overall medical costs and complication rate.

RESULTS

Postoperative time to readiness for discharge was significantly shorter in the ERAS group (6.0 (2.0∼14.0) days) than the control group (7.0 (4.0∼16.0) days, P = 0.01), and the duration of ICU stay and duration of mechanical ventilation were significantly shorter in the ERAS group (20.9 (13.5∼69.3) h, 7.2 (0.0∼22.3) h, respectively) than the control group (22.0 (13.4∼212.3) h, P = 0.001; 8.8 (3.7∼44.9) h, respectively; P < 0.0001). The overall treatment cost of the ERAS group (69202 (52089∼123823) CNY) was significantly lower than that of the control group (77058 (51390∼144290) CNY, P = 0.002).

CONCLUSIONS

ERAS pathways reduce the length of ICU and hospital stay, postoperative complications and cost for patients undergoing cardiac surgery.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov: NCT02479581.

摘要

目的

加速康复外科(ERAS)路径尚未在心脏外科中报道。本研究旨在评估与常规护理相比,ERAS 路径用于心脏瓣膜手术患者的临床效果和安全性。

方法

这是一项在 2015 年 7 月至 2016 年 11 月期间进行的随机临床试验。共纳入 226 例行择期瓣膜手术的患者,随机分配至 ERAS 路径或常规护理(对照组)组。ERAS 方案包括基于证据的围手术期患者管理的系统优化方法。对照组接受常规护理。主要终点为准备出院。次要结局为 ICU 住院时间、术后血管活性药物支持时间、机械通气时间、首次排便时间、引流管拔除时间、总医疗费用和并发症发生率。

结果

ERAS 组患者术后准备出院的时间明显短于对照组(6.0(2.0∼14.0)天 vs. 7.0(4.0∼16.0)天,P=0.01),且 ICU 住院时间和机械通气时间也明显短于对照组(20.9(13.5∼69.3)小时,7.2(0.0∼22.3)小时 vs. 22.0(13.4∼212.3)小时,P=0.001;8.8(3.7∼44.9)小时,P<0.0001)。ERAS 组的总治疗费用(69202(52089∼123823)元)明显低于对照组(77058(51390∼144290)元,P=0.002)。

结论

ERAS 路径可减少心脏手术患者的 ICU 和住院时间、术后并发症和费用。

临床试验注册

ClinicalTrials.gov:NCT02479581。

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