局部组织黏合剂固定中心静脉导管在心脏手术患者中的有效性：一项随机对照初步研究。

Effectiveness of securing central venous catheters with topical tissue adhesive in patients undergoing cardiac surgery: a randomized controlled pilot study.

机构信息

Department of Anesthesiology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.

出版信息

BMC Anesthesiol. 2021 Mar 8;21(1):70. doi: 10.1186/s12871-021-01282-0.

DOI:10.1186/s12871-021-01282-0

PMID:33685394

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7938567/

Abstract

BACKGROUND

Central venous catheters (CVCs) play an important role during cardiac surgery. Topical tissue adhesives form a thin film of coating that becomes bound to keratin in the epidermis. The advantage of this "super glue" lies in its antimicrobial activity. This study aimed to evaluate fixation of CVCs with topical tissue adhesive in patients (prone to bleed) undergoing cardiac surgery regarding its ability to reduce the incidence of pericatheter leakage.

METHODS

This randomized controlled trial included 150 patients > 15 years of age who were (1) scheduled to undergo elective cardiac surgery, (2) required CVC insertion at the internal jugular vein, and (3) scheduled for transfer postoperatively to the cardiac intensive care unit. We randomly assigned patients to a topical tissue adhesive group (TA) or a standard control group (SC). The primary outcome was a change in dressing immediately postoperatively due to pericatheter blood oozing. Secondary outcomes were the number of dressings, total dressings per catheter day, and composite outcome of catheter failure within 3 days. Both intention-to-treat and per-protocol analyses were performed. Seven patients violated the protocol (three TA patients and four SC patients).

RESULTS

Regarding the primary outcome, the SC group exhibited a significantly increased incidence of dressing change immediately postoperatively due to pericatheter leakage compared with the TA group in both the intention-to-treat analysis (5.33% vs 18.67%, RR 0.25 [95% CI 0.08 to 0.79], P = 0.012) and the per-protocol analysis (5.56% vs 16.90%, RR 0.289 [95% CI 0.09 to 0.95], P = 0.031). No significant differences were noted in the number of dressings, total dressings per catheter day, or composite outcome of catheter failure within 3 days between the two groups. Multiple logistic regression analysis was performed to adjust baseline characteristics that were different in the per-protocol analysis. The results showed that the risk ratio of immediate postoperative dressing change in TA patients was 0.25 compared to the SC group ([95% CI 0.07 to 0.87], P = 0.029) in the per-protocol analysis.

CONCLUSION

The use of a topical tissue adhesive can reduce the incidence of immediate postoperative pericatheter blood oozing.

TRIAL REGISTRATION

TCTR20180608004 , retrospectively registered on June 06, 2018.

摘要

背景

中心静脉导管（CVC）在心脏手术中起着重要作用。局部组织粘合剂形成一层薄的涂层，与表皮中的角蛋白结合。这种“超级胶水”的优点在于其抗菌活性。本研究旨在评估局部组织粘合剂固定 CVC 在心脏手术患者（易出血）中的应用，以减少导管周围渗漏的发生率。

方法

这是一项随机对照试验，纳入了 150 名年龄大于 15 岁的患者，（1）计划接受择期心脏手术，（2）需要在内颈静脉插入 CVC，（3）计划术后转至心脏重症监护病房。我们将患者随机分配到局部组织粘合剂组（TA）或标准对照组（SC）。主要结局是术后立即因导管周围血液渗出而更换敷料。次要结局是导管日的敷料数量、总敷料数量和 3 天内导管失败的复合结局。进行意向治疗和方案分析。有 7 名患者违反了方案（3 名 TA 患者和 4 名 SC 患者）。

结果

在主要结局方面，与 TA 组相比，SC 组在意向治疗分析（5.33% vs 18.67%，RR 0.25 [95% CI 0.08 至 0.79]，P=0.012）和方案分析（5.56% vs 16.90%，RR 0.289 [95% CI 0.09 至 0.95]，P=0.031）中，术后立即更换敷料的发生率显著增加。两组间导管日的敷料数量、总敷料数量或 3 天内导管失败的复合结局无显著差异。进行了多因素逻辑回归分析，以调整方案分析中存在差异的基线特征。结果表明，在方案分析中，与 SC 组相比，TA 组患者术后立即更换敷料的风险比为 0.25（95%CI 0.07 至 0.87]，P=0.029）。