Effect of Cold Pressure in the Prevention of Hematoma and Ecchymosis

NCT05553821 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2022-09-23

No results posted yet for this study

Summary

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.

Conditions

  • Clinical Nursing Research

Interventions

OTHER

Cold sand bag

A sand bag weighing 3.5-4 kg is applied to the CAG area of patients.

OTHER

A sand bag

A sand bag

Sponsors & Collaborators

  • Eskisehir Osmangazi University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-03
Primary Completion
2022-04-30
Completion
2022-04-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05553821 on ClinicalTrials.gov