Comparison of the Effectiveness of the FemoStop Device and Sandbag Pressure on Hemostasis During Sheath Removal and Reducing Puncture Site Complications Following Transfemoral Coronary Angiography: A Randomized Controlled Trial

Abstract

Background: Management of common and unpleasant complications following the removal of the arterial sheath is one of the goals and priorities of nursing care in patients undergoing angiography. Objectives: This study aimed to design and manufacture a FemoStop device and compare its effectiveness with sandbag pressure on hemostasis during sheath removal and reducing puncture site complications following transfemoral coronary angiography. Methods: This randomized controlled trial was conducted between 2019 and 2021. Eighty patients undergoing elective transfemoral coronary angiography referred to a Heart and Vascular Hospital in Tehran were recruited by convenience sampling and were randomly assigned to experimental (n = 40) and control (n = 40) groups. FemoStop devices and sandbags were used in the experimental and control groups to control angiography complications, respectively. The patient’s individual characteristics questionnaire, visual analog scale, checklist of complications, and laboratory indicators were used for data collection. Pain intensity, heart rate, respiratory rate, temperature, systolic and diastolic blood pressure, arterial oxygen saturation, and the amount of hematoma and bleeding of patients before, after 15 minutes, 1 h, 2 h, 2.5 h, 3 h, 3.5 h, 4 h, 4.5 h, 5 h, and 6 h were measured after the intervention. Results: The trend of changes in pain intensity (P < 0.001), heart rate (P = 0.036), and systolic blood pressure (P < 0.001) of patients in the experimental and control groups after the intervention was significant, and in patients who had used the FemoStop device, it was less than the control group. However, the changes in respiratory rate (P = 0.308), diastolic blood pressure (P = 0.089), arterial oxygen saturation (P = 0.205), and temperature (P = 0.195) of patients in the 2 groups were not significant. The 2 groups were not significantly different in terms of these variables and the amount of hematoma and bleeding in the 12 stages of measurement. Conclusions: Compared to using a sandbag after transfemoral coronary angiography, the FemoStop device leads to fewer complications, such as pain intensity, lower heart rate, and systolic blood pressure in patients. Therefore, considering fewer complications, it is suggested to conduct more studies to confirm the use of this device to control complications in patients.