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IRCT20200410047011N2 IRCT 2022-12-13 Artesh University of Medical Sciences Designing and manufacturing of an inflatable thigh strap and evaluating its effectiveness on hemostasis during sheet removal and prevention of complications after transfemoral coronary angiography. Designing and manufacturing of an inflatable thigh strap and evaluating its effectiveness on hemostasis during sheet removal and prevention of complications after transfemoral coronary angiography in patients referring to hospital. 2020-10-22 anticipated 80 Complete https://irct.ir/trial/66186 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 80 patients were included in the study by available sampling method and were divided into experimental and control groups based on the day of visit by coin toss. In this way, the patients who were visited on Sundays were included in the experimental group and they used an inflatable thigh strap, and the patients who visited on Mondays were in the control group and used sandbags according to the hospital routine. N/A patients with coronary artery disease undergoing transfemoral coronary angiography. Intervention 1: Intervention group: In the test group, an inflatable thigh starp was used to maintain hemostasis and prevent bleeding and hematoma immediately after the removal of the femoral sheath and hemostasis by hand in the Catheterization Laboratory by a trained nurse according to the protocol determined based on point pressure at the puncture site of the artery, the femoral was closed. The tourniquet was left in place for 4 to 6 hours and then opened. All procedures were performed under the supervision of a physician. Intervention 2: Control group: according to the hospital routine, a sandbag was used instead of an inflatable thigh strap. The weight of the sandbag was 2.5 kg, which was placed in the puncture site of the femoral artery for 6 hours. In all stages, patients of the control group had to keep their legs straight. When the patient was in a semi-sitting position, a pillow was placed on the patient’s back. Yes - There is a plan to make this available What will be shared: This study was approved by the Ethics Committee of Aja University of Medical Sciences (code IR.AJAUMS.REC.1399.133). The provisions of the Declaration of Helsinki were observed in this study. Patients entered the study voluntarily and could withdraw from the study whenever they wished. Also, the purpose of the study was explained to the patients and written informed consent was obtained from all patients. The researchers were obliged to ensure that the patients did not suffer physical harm and all possible side effects of the intervention were monitored and, if necessary, appropriate measures were replaced. The confidentiality of all data and the confidentiality of the information sources used were also observed. When: 6 months after printig results To whom: This study was approved by the Ethics Committee of Aja University of Medical Sciences (code IR.AJAUMS.REC.1399.133). The provisions of the Declaration of Helsinki were observed in this study. Patients entered the study voluntarily and could withdraw from the study whenever they wished. Also, the purpose of the study was explained to the patients and written informed consent was obtained from all patients. The researchers were obliged to ensure that the patients did not suffer physical harm and all possible side effects of the intervention were monitored and, if necessary, appropriate measures were replaced. The confidentiality of all data and the confidentiality of the information sources used were also observed. Conditions: This study was approved by the Ethics Committee of Aja University of Medical Sciences (code IR.AJAUMS.REC.1399.133). The provisions of the Declaration of Helsinki were observed in this study. Patients entered the study voluntarily and could withdraw from the study whenever they wished. Also, the purpose of the study was explained to the patients and written informed consent was obtained from all patients. The researchers were obliged to ensure that the patients did not suffer physical harm and all possible side effects of the intervention were monitored and, if necessary, appropriate measures were replaced. The confidentiality of all data and the confidentiality of the information sources used were also observed. Where to obtain: Hojjat Niknam Sarabi, +98 9125574438, offface92@gmail.com How to obtain: Send email to the responsible author, confirmation by authors, confirmation by army univarsity of medical sciences, provide data Comments:
public Hojjat Niknam Sarabi
Army 502 Haspital, Taleghani Ave, Junc Bahar North st, TEHRAN, IRAN
Tehran Iran (Islamic Republic of) 1571755511 +98 21 8830 7020 Offface92@gmail.com Artesh University of Medical Sciences scientific Hojjat Niknam Sarabi
Army 502 Haspital, Taleghani Ave, Junc Bahar North st, TEHRAN, IRAN
Tehran Iran (Islamic Republic of) 1571755511 +98 21 8830 7020 Offface92@gmail.com Artesh University of Medical Sciences Iran (Islamic Republic of) being alert not suffering from hemophilia and coagulation disorders age between 45 and 70 years candidate for femoral angiography 45 years 70 years Both refusal to continue cooperation the occurrence of complications such as bleeding hematoma, and abnormal pain during the intervention use of painkillers or narcotics before, during, and after transfemoral coronary angiography. Y84.0 Cardiac catheterization as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure Treatment - Devices Treatment - Devices Intervention group: In the test group, an inflatable thigh starp was used to maintain hemostasis and prevent bleeding and hematoma immediately after the removal of the femoral sheath and hemostasis by hand in the Catheterization Laboratory by a trained nurse according to the protocol determined based on point pressure at the puncture site of the artery, the femoral was closed. The tourniquet was left in place for 4 to 6 hours and then opened. All procedures were performed under the supervision of a physician. Control group: according to the hospital routine, a sandbag was used instead of an inflatable thigh strap. The weight of the sandbag was 2.5 kg, which was placed in the puncture site of the femoral artery for 6 hours. In all stages, patients of the control group had to keep their legs straight. When the patient was in a semi-sitting position, a pillow was placed on the patient’s back. Groin pain: groin pain refers to a feeling of discomfort in the area where the abdomen ends and the legs begin. Timepoint: Three trained and experienced nurses as researcher’s assistants using a chart (before and immediately after closing the FemoStop device, 15 minutes, one hour, two hours, two and a half hours, three hours, three hours and a half, four hours, four and a half hours, five hours, and six hours after closing the FemoStop device, totally of 12 times) recorded and reported all possible complications. Method of measurement: The Visual Analog Scale will be used to measure groin pain. The Visual Analog Scale is used to measure pain. The visual analog scale is the evaluation of pain intensity as a 10 cm horizontal line numbered from 0 to 10 (zero indicates the absence of pain and 10 indicates the most severe pain possible). Hematoma: Localized bleeding outside the blood vessels, which occurs due to illness or trauma, including injury or surgery, and may lead to continued bleeding from broken capillaries. The hematoma is benign and initially spreads as fluid between tissues, including the interstitial sacs, which may coagulate and solidify in the blood vessels before reabsorption. Timepoint: Three trained and experienced nurses as researcher’s assistants using a chart (before and immediately after closing the FemoStop device, 15 minutes, one hour, two hours, two and a half hours, three hours, three hours and a half, four hours, four and a half hours, five hours, and six hours after closing the FemoStop device, totally of 12 times) recorded and reported all possible complications. Method of measurement: The Christensen scale was used to measure hematoma. Leg pain: Prickle, cramping, fatigue and sometimes burning in the legs caused by poor blood circulation in the arteries of the legs. Timepoint: Three trained and experienced nurses as researcher’s assistants using a chart (before and immediately after closing the FemoStop device, 15 minutes, one hour, two hours, two and a half hours, three hours, three hours and a half, four hours, four and a half hours, five hours, and six hours after closing the FemoStop device, totally of 12 times) recorded and reported all possible complications. Method of measurement: The Visual Analog Scale will be used to measure leg pain. The Visual Analog Scale is used to measure pain. The visual analog scale is the evaluation of pain intensity as a 10 cm horizontal line numbered from 0 to 10 (zero indicates the absence of pain and 10 indicates the most severe pain possible). Bleeding: Any bleeding that comes out of the circulatory system due to damage to the blood vessels is called bleeding. Bleeding may be due to vascular disorders, platelets, coagulation factors, coagulation inhibitors, exacerbation of fibrinolysis, or a combination of these factors. Typically, a healthy person can lose 10 to 15% of their total blood volume without serious medical problems. Tolerate. Timepoint: Three trained and experienced nurses as researcher’s assistants using a chart (before and immediately after closing the FemoStop device, 15 minutes, one hour, two hours, two and a half hours, three hours, three hours and a half, four hours, four and a half hours, five hours, and six hours after closing the FemoStop device, totally of 12 times) recorded and reported all possible complications. Method of measurement: En The amount of blood loss will be calculated based on the amount of bleeding based on the number of blood-soaked gases. Given that each 4 in 4 blood gasses in blood is about 10 ml of blood, then the amount of bleeding during 6 hours calculated by multiplying the number of gases collected in 10 Will take. Prothrombin time (PT), Partial thromboplastin time (PTT), international normalized ratio (INR). Timepoint: Before intervention. Method of measurement: Laboratory indicators were measured in the hospital laboratory. Hemodynamic indicators (systolic and diastolic blood pressure, temperature, respiratory rate, heart rate, and arterial oxygen saturation (Sao2)). Timepoint: Three trained and experienced nurses as researcher’s assistants using a chart (before and immediately after closing the FemoStop device, 15 minutes, one hour, two hours, two and a half hours, three hours, three hours and a half, four hours, four and a half hours, five hours, and six hours after closing the FemoStop device, totally of 12 times) recorded and reported all possible complications. Method of measurement: The hemodynamic indicators of the patients were recorded by the monitoring device. The temperature was measured with a thermometer. Artesh University of Medical Sciences Approved 2020-10-12 Army University of Medical Sciences Etemadzade st, Ave Fatemi, TEHRAN, IRAN Tehran Tehran Iran (Islamic Republic of)