心導管檢查後接受傳統加壓與使用血管內閉合器止血者其穿刺部位合併症發生率與舒適程度之差異

Abstract

隨著飲食與生活型態的改變，國人罹患心臟疾病的比率日益上升，心導管技術漸趨成熟，冠狀動脈心臟病者接受心導管治療也成為主流，檢查結束移除導管後除了一般傳統加壓止血外，近年來臨床上也陸續使用血管內閉合器(Angio-seal)止血，其引發之合併症與傳統止血方式比較，尚無類似研究報告，故本研究旨在探討經鼠蹊動脈穿刺之診斷性或治療性心導管檢查後接受傳統加壓與使用血管內閉合器止血者其穿刺部位合併症發生率、是否接受導尿與舒適程度之差異及影響合併症發生之因素。 本研究為類實驗性研究，採立意取樣，以北部某醫學中心心臟科病房之病人為研究對象，依其選擇之止血方式分配至採血管內閉合器Angio-seal止血之實驗組與傳統加壓止血之控制組，自2011年9月29日至2012年8月26日，共收案130名，每組各65名。控制組病人於導管移除後臥床足12小時以上之下床時間(隔日清晨)觀察其穿刺部位合併症發生情形，而實驗組病人則於導管移除後1小時、4小時及12小時(隔日清晨)進行穿刺部位合併症之觀察；此外，於導管移除後1小時與下床前(控制組：導管移除後12小時、實驗組：導管移除後4小時)以數字等級量表評估背部、鼠蹊穿刺部位與腿部酸、麻、痛等不適程度。將所得資料以SPSS for Windows16.0統計套裝軟體進行資料分析，針對病人基本屬性以描述性統計方式呈現、T test比較兩組間連續變項之差異及卡方檢定比較兩組間類別變項之差異，再以邏輯斯迴歸模式預測合併症發生之因素。 研究結果發現：(1)總合併症發生率為3.8%，實驗組為7.7% (n=5)，而控制組無合併症發生(0%)，兩組間合併症發生情形無顯著差異(P=0.06)。(2)兩組間接受導尿情形無顯著差異(P=0.37)。(3)兩組間舒適程度於移除導管後1小時背部酸(P=0.00)與穿刺部位疼痛(P=0.02)及下床時背部酸(P=0.00)與腿部麻(P=0.02)等方面具顯著差異，實驗組舒適程度顯著高於控制組。(4)年齡及是否罹患糖尿病為穿刺部位合併症之顯著預測因素，其中年齡超過70歲者之合併症發生率為年齡小於或等於70歲者之17.29倍；有糖尿病者其合併症發生率為無糖尿病者之14.29倍。本研究結果顯示與傳統加壓方式比較，使用血管內閉合器止血者其合併症不會增加，但舒適程度增加。

Through the changing of diet and lifestyle of people, the rates of population who suffer heart disease are increasing. Cardiac catheterization technology is getting mature gradually; therefore, cardiac catheterization therapy has also become the mainstream treatment for patients who suffer coronary heart disease. After cardiac catheterization and sheath removing, in addition to manual compression, vascular closure device (Angio-seal) has also been used as artery hemostasis in recent years. Comparing the complications that occurred from manual compression and Angio-seal, there is still no related research reported; therefore, the aim of this study is to evaluate the different effects of two different ways of hemostasis, manual compression hemostasis and Angio-seal hemostasis, in the rates of complication on the puncture site and receiving foley catheterization, the comfort level, and the factors that might cause complications after diagnostic or therapeutic cardiac catheterization transfemoral artery approach. The research design of the study was Quasi experimental design. Purposive sampling technique was used. Patients from cardiovascular medical ward of a medical center are the target sample of our research. They were divided in experimental group, which use Angio-seal as hemostasis; and control group, which use manual compression as hemostasis. From Sep 29th, 2011 to Aug 26th, 2012, there were 130 patients being observed and 65 patients in each group. In control group, after the sheath removing, puncture site complications of patients were observed after 12 hours after out of bed. In experimental group, puncture site complications of patients were observed at 1 hour, 4 hours, and 12 hours after the remove of sheath. In addition, assessing the level of sore, numbness, pain on patients’ back, the puncture site, and leg were evaluated and recorded using the numeric rating scale at 1 hour after sheath removing and before out of bed( In control group, the data were evaluated at 1 hour and 12 hours after sheath removing and in experimental group, the data were evaluated at 1 hour and 4 hours). SPSS for Windows 16.0 statistic package software was used to process the data analysis. For patients’ demographic information, descriptive statistic method was used to present. T-test was used to compare the continuous variable differences between two groups, and Chi-square was used to compare the categorical variable differences between two groups. Furthermore, logistic regression models were used to predict factors of complications. In the result, it has been discovered that (1) the incidence of total complications are 3.8%, 7.7%(n=5) in experimental group, and 0% in control group, which there is no complications occurred. In both group, there is no significant differences in complications (P=0.06). (2) there is no significant differences when reciving foley catheterization in both groups (P=0.37). (3) there are significant differences of the comfort levels on the sore of back (P=0.00) and the pain on puncture site (P=0.02) at 1 hour after removing sheath, and the sore of back (P=0.00) and the numbness of leg (P=0.02) before out of bed. The comfort levels in experimental group are significantly higher than those in control group. (4) age and diabetes are two major factors to indicate whether there is puncture site complications occurred. The incidences of complications in populations who are above 70 years old are 17.29 times than those who are below or equal to 70 years old. The incidences of complications in patients with diabetes are 14.29 times than patients without diabetes. In the result of our research indicated that using Angio-seal as hemostasis do not increase the complications but do increase the comfort levels of patients, comparing with manual compression.