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电子与传统胸腔引流系统客观和主观结果的多中心国际随机对照研究

Multicenter international randomized comparison of objective and subjective outcomes between electronic and traditional chest drainage systems.

作者信息

Pompili Cecilia, Detterbeck Frank, Papagiannopoulos Kostas, Sihoe Alan, Vachlas Kostas, Maxfield Mark W, Lim Henry C, Brunelli Alessandro

机构信息

Department of Thoracic Surgery, Ospedali Riuniti Ancona, Ancona, Italy.

Department of Thoracic Surgery, Yale-New Haven Hospital, Yale University, New Haven, Connecticut.

出版信息

Ann Thorac Surg. 2014 Aug;98(2):490-6; discussion 496-7. doi: 10.1016/j.athoracsur.2014.03.043. Epub 2014 Jun 4.

Abstract

BACKGROUND

The aim of this study was to assess the impact of digital versus traditional drainage devices on chest tube removal and patient satisfaction.

METHODS

A randomized trial of digital versus traditional devices after lobectomy/segmentectomy was conducted at 4 international centers (United Kingdom, Europe, Asia, United States). Patients were managed with overnight suction followed by gravity drainage. Chest tubes were removed when an air leak was not evident anymore and the drained fluid was less than 400 mL/d.

RESULTS

The groups (digital, 191 patients; traditional, 190 patients) were well matched for baseline and surgical characteristics. There were 325 lobectomies/bilobectomies and 56 segmentectomies, 308 of which were performed by video-assisted thoracic surgery (VATS). Patients randomized to digital systems had a significantly shorter air leak duration (1.0 versus 2.2 days; p=0.001), duration of chest tube placement (3.6 versus 4.7 days; p=0.0001), and postoperative length of stay (4.6 versus 5.6 days; p<0.0001). Subjective end points revealed a perceived improved ability to arise from bed (p=0.008), system convenience for patients and personnel (p=0.02), and the potential for being comfortable when discharged home with the device (p=0.06). A mean difference of 2.6 days from air leak cessation to tube removal was observed, which was similar in the 2 groups (p=0.7). Multivariable regression analysis showed that duration of chest tube placement after air leak cessation was directly associated with the amount of fluid drained during the first 48 hours (p=0.01) and the duration of air leak (p=0.008), independent of hospital location.

CONCLUSIONS

Patients managed with digital drainage systems experienced a shorter duration of chest tube placement, shorter hospital stays, and higher satisfaction scores compared with those managed with traditional devices. (

CLINICAL TRIAL REGISTRATION NUMBER

NCT01747889.).

摘要

背景

本研究旨在评估数字式与传统引流装置对胸腔引流管拔除及患者满意度的影响。

方法

在4个国际中心(英国、欧洲、亚洲、美国)进行了一项关于肺叶切除/肺段切除术后数字式与传统装置的随机试验。患者术后接受过夜负压吸引,随后改为重力引流。当不再有明显漏气且引流量小于400 mL/天时拔除胸腔引流管。

结果

两组(数字式组191例患者;传统组190例患者)在基线和手术特征方面匹配良好。共进行了325例肺叶切除/双肺叶切除和56例肺段切除,其中308例通过电视辅助胸腔镜手术(VATS)完成。随机分配至数字式系统的患者漏气持续时间显著缩短(1.0天对2.2天;p = 0.001)、胸腔引流管留置时间缩短(3.6天对4.7天;p = 0.0001)以及术后住院时间缩短(4.6天对5.6天;p < 0.0001)。主观终点显示,患者感觉起床能力有所改善(p = 0.008)、该系统对患者和医护人员都更方便(p = 0.02),并且携带该装置出院回家时有可能感觉舒适(p = 0.06)。观察到从漏气停止到引流管拔除的平均时间差为2.6天,两组相似(p = 0.7)。多变量回归分析显示,漏气停止后胸腔引流管留置时间与最初48小时内的引流量(p = 0.01)和漏气持续时间(p = 0.008)直接相关,与医院位置无关。

结论

与使用传统装置的患者相比,使用数字式引流系统的患者胸腔引流管留置时间更短、住院时间更短且满意度得分更高。(临床试验注册号:NCT01747889。)

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