Department of Cardiology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Clinical Research Center, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
J Interv Card Electrophysiol. 2022 Mar;63(2):275-281. doi: 10.1007/s10840-021-00973-5. Epub 2021 Mar 6.
AIM/OBJECTIVE: Aim to evaluate the safety and effectiveness of a pocket compression device in patients undergoing cardiovascular implantable electronic device (CIED) implantation.
This randomized controlled trial included 54 patients in the control group (elastic adhesive tape) and 54 patients in the experimental group (pocket compression device). A sandbag was positioned over the pocket after CIED implantation, using elastic adhesive tape in the control group and a novel pocket compression device in the experimental group. The primary outcome was the incidence of pocket hematomas, and the secondary outcomes were adverse skin reactions, the need for sandbag positional adjustments, and patient comfort.
The distributions of age, sex, and clinical and procedure characteristics was not significantly different between the two groups (P>0.05). The occurrence of hematomas was lower when using the pocket compression device than in the control group (13.0% vs. 44.4%, P<0.001). The incidence rates of hematomas of grades 1 and the grade 2 hematomas were significantly lower in the experimental group than in the control group (13.0% vs. 31.5%, 0% vs. 11.1% respectively, [all P<0.05]). The incidence rates of adverse skin reactions and sandbag positional adjustments were much lower and the patient comfort score was significantly higher in the experimental group than in the control group (all P<0.001).
A pocket compression device can significantly decrease the incidence of pocket hematomas, adverse skin reactions, and positional adjustments when patients are undergoing CIED, which can improve patient comfort and decrease the nursing workload.
GOV : NCT04389398.
目的/目标：评估在接受心血管植入式电子设备（CIED）植入的患者中使用口袋压迫装置的安全性和有效性。
这是一项随机对照试验，纳入了对照组（弹性胶带）的 54 例患者和实验组（口袋压迫装置）的 54 例患者。在 CIED 植入后，在口袋上方放置沙袋，对照组使用弹性胶带，实验组使用新型口袋压迫装置。主要结局是口袋血肿的发生率，次要结局是不良皮肤反应、沙袋位置调整的需要以及患者舒适度。
两组患者的年龄、性别和临床及手术特征分布无显著差异（P>0.05）。使用口袋压迫装置时血肿的发生率低于对照组（13.0% vs. 44.4%，P<0.001）。实验组的血肿 1 级和 2 级血肿发生率明显低于对照组（13.0% vs. 31.5%，0% vs. 11.1%，均 P<0.05）。实验组不良皮肤反应和沙袋位置调整的发生率明显低于对照组，患者舒适度评分明显高于对照组（均 P<0.001）。
在接受 CIED 的患者中，口袋压迫装置可显著降低口袋血肿、不良皮肤反应和位置调整的发生率，从而提高患者舒适度，降低护理工作量。
注册号：NCT04389398。
