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临床试验/NCT05553821
NCT05553821已完成不适用

Evaluation of the Effect of Cold Pressure Application in the Prevention of Hematoma and Ecchymosis After Percutan Coronary Intervention

Eskisehir Osmangazi University2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2021年11月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
210
试验地点
2
主要终点
Assesment of vascular complications and pain

研究概览

简要总结

Coronary Artery Disease (CAD) is the most common cardiovascular system disease. According to the World Health Organization data, CAD ranks first among the top 10 causes of death. According to the 2014 data of the Turkish Statistical Institute (TUIK), deaths due to circulatory system diseases are in the first place with 40.4%, and 39.6% of this is ischemic heart diseases. The prevalence of CAD in Turkey is 12% in women and 14% in men. The diagnosis of CAD is largely made on non-invasive tests. Coronary angiography (CAG) is recommended for definitive diagnosis and detection of coronary stenosis. CAG is defined as the manual delivery of contrast material through a catheter sent to the coronary arteries under fluoroscopy and recording the resulting image on a CD. With special catheters advanced through a plastic sheath called a sheath placed in the access tract, contrast agents are administered separately to the left main coronary (LDA) and right main coronary arteries (RCA), and images of the coronary arteries are taken in multiple positions.

Complications related to diagnostic and therapeutic CAG are rare, but vary according to the patient's condition, operator's experience, and the type of procedure. The most common vascular complications are bleeding, hematoma, ecchymosis, pseudoaneurysm, retroperitoneal hemorrhage, arteriovenous fistula. Preventing complications before they develop is actually shown as the most successful treatment. For this reason, it is recommended to use a small-diameter catheter during CAG, to enter the main femoral artery carefully, to interrupt anticoagulant treatment before the procedure, to apply manual compression to the area for at least 20 minutes after the procedure, and to use percutaneous closure devices, which is another method. After the procedure, pressure is applied with a sandbag, manual compression, and a pneumatic compression device. In the sandbag method, a 3-4.5 kg sandbag is placed after the bleeding is controlled by manual pressure on the femoral region where the intervention is made. During this period, the patient's movements are restricted and he is asked to lie flat on his back. In the use of the pneumatic compression device, a pneumatic compression device (closepad) with a transparent window and balloon incision is placed to maintain the compression on the femoral artery after a short period of manual compression. However, it is not preferred because of the risk of embolism and high cost.

In addition to pressure applications, local cold application is effective in preventing perivascular complications. Cold application controls bleeding by reducing capillary blood flow and capillary permeability by vasoconstriction of arterioles. In addition, it reduces the flow rate of the blood and increases its viscosity, thereby making it coagulate. It controls bleeding by blood coagulation, reduced capillary permeability and metabolic requirements. This situation reduces the development of ecchymosis and hematoma. Considering this information, cold application can be preferred for the prevention of hematoma and ecchymosis, which are the most common complications after CAG, because it is practical, inexpensive and comfort-enhancing. The number of studies in the literature in which cold application and pressure application are used together is limited. Based on this information, the current study was planned to evaluate the effectiveness of cold pressure application for the prevention of hematoma and ecchymosis in the CAG intervention area. The hypotheses of the research; H0: Cold pressure application has no effect on the prevention of hematoma and ecchymosis in the CAG intervention area.

H1: Cold pressure application has an effect on the prevention of hematoma and ecchymosis in the CAG intervention area.

详细描述

MATERIALS AND METHODS Purpose and type of research This study was planned as a randomized controlled intervention study to evaluate the effect of local cold pressure application on the prevention of hematoma and ecchymosis in patients undergoing CAG via the femoral artery.

Dependent, independent and control variables of the study:

Dependent variables; The dependent variable of this study is the development of bleeding, hematoma and ecchymosis, pain after CAG.

Independent variables; Application of cold pressure applied to patients. Control variables: Patient's age, gender, type of procedure, blood pressure, thrombocyte, Pt, Ptz, INR values, heparin dose administered during CAG (60. IU/kg) Place and time of research The research will be carried out in Eskişehir City Hospital Cardiology and Coronary Intensive Care 1,2 services between Nowember 01, 2021 and June 01, 2022.

Eskişehir City Hospital Cardiology Service: It started to serve in October 2018. In the 24-bed cardiology service, patients with diagnoses such as heart failure, rhythm disorder, and chest pain are generally hospitalized. The number of physicians is 10. The number of nurses is 11.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • over 18 years old
  • Conscious
  • Patients who underwent CAG for the first time and/or did not undergo CAG in the last 1 year (it is stated that the recovery period in the femoral intervention area after CAG is completed in 3 months (54). Based on this information, in the study, patients who had CAG before had at least 1 year from CAG. criteria have been determined),
  • Platelet values within normal limits,
  • Patients treated with 10,000 units or less of heparin during angiography.

排除标准

  • Patients who do not agree to participate in the study and/or want to exit the study while continuing the research,
  • Those who developed vascular complications in the region before sheat extraction,
  • Those who routinely use anticoagulant drugs,
  • Those receiving antithrombotic drug (clotinab) treatment,
  • Those with peripheral vascular disease.

结局指标

主要结局

Assesment of vascular complications and pain

时间窗: First hour

Diameters of hematoma and ecchymosis (mm) and score of Visual Analog Scale

次要结局

  • Assesment of vascular complications and pain(Twenty forth hour)

研究者

发起方
Eskisehir Osmangazi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gülzade Duygun Pamuk

Principal investigator

Eskisehir Osmangazi University

研究点 (2)

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