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IRCT20211121053121N2 IRCT 2021-12-04 Isfahan University of Medical Sciences Comparative study of vascular complications related to arterial sheet extraction using clamp ease device and hand pressure in patients undergoing angiography. - Comparative of vascular complications related to arterial sheet extraction using clamp ease and hand pressure in patients undergoing angiography. 2021-12-06 anticipated 94 Complete https://irct.ir/trial/60341 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is an experimental study with two groups (manual method group and clampase method group) randomly and prospectively during which two groups of patients a doctor is randomly selected and divided into groups with hand pressure and the group using clampase device, Randomization description: In this study, initial sampling is easy and sample allocation between the two groups is done randomly so that patients with Odd file number (patients with the last digit of individual file number) in the group of arterial sheet exit by hand and patients with Even file number (patients with the last digit of the even number) are in the group of using the clamp ease device. N/A This study is performed in the field of vascular injuries after the invasive action of arterial sheet removal. Intervention group: The intervention group consists of 47 patients of a specific physician who refer to the angiography department on an outpatient basis for angiography.In this group, which are randomly selected and available, one of the types of Vascular closing devices (VCDs) available in Iran, which was made in California, USA in 2005 and widely distributed around the world, including Shahid Chamran Hospital in Isfahan. Used to exit the sheet.This device, which includes a flat plate to be placed under the patient, a height-adjustable base that can be changed depending on the patient's thigh size, and a transparent sterile plate that is changed from patient to patient to reduce the risk of disease transmission.In both Method, after the necessary training, we proceed to remove the arterial sheet. After removing the sheet, the clamp device is fixed on the patient's artery. After 20 minutes, if there is no bleeding, the device returns completely and the patient is examined for bleeding Hematoma and ecchymosis are evaluated.for 24 hours. Another method is to remove the arterial sheet: The manual method is to remove the sheet, which is the usual method of removing the sheet, which is similar to the previous method. To ensure the absence of bleeding, the hand pressure is removed and the patient is examined for hematoma bleeding and ecchymosis for 24 hours.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I have not decided yet, but if you agree, I have no problem with publishing the data
public Syed Abas Hosseini
Hezar Jerib St., Isfahan University of Medical Sciences, School of Nursing, Management and Rehabilitation
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7504 a-hoseini@nm.mui.ac.ir Isfahan University of Medical Sciences scientific Syed Abas Hoseini
Hezar Jerib St., Isfahan University of Medical Sciences, School of Nursing, Management and Rehabilitation
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7504 a-hoseini@nm.mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) Informed consent to participate in the study International normal ratio less than 1.8 had not a surgical incision on the femoral artery in the past week. (35) Use the minimum dose of heparin (less than 5000) units during angiography (36) The patient has not received anticoagulants in other centers (rateplase, streptokinase, altplase) (7). Absence of previous hematoma and ecchymosis during the angiographic procedure in Cat Lab or during recent hospitalization (35) The patient should not have osteoporosis (37) The patient underwent angiography through the femoral artery. The process of implantation of arterial sheet and angiography of the patient should be performed by a specific doctor. Lack of history of femoral and pelvic surgeries, including femoral head replacement and pelvic bone fractures (38) no limit no limit Both Does not exist I51.6 cardiovascular disease NOS Treatment - Devices Intervention group: The intervention group consists of 47 patients of a specific physician who refer to the angiography department on an outpatient basis for angiography.In this group, which are randomly selected and available, one of the types of Vascular closing devices (VCDs) available in Iran, which was made in California, USA in 2005 and widely distributed around the world, including Shahid Chamran Hospital in Isfahan. Used to exit the sheet.This device, which includes a flat plate to be placed under the patient, a height-adjustable base that can be changed depending on the patient's thigh size, and a transparent sterile plate that is changed from patient to patient to reduce the risk of disease transmission.In both Method, after the necessary training, we proceed to remove the arterial sheet. After removing the sheet, the clamp device is fixed on the patient's artery. After 20 minutes, if there is no bleeding, the device returns completely and the patient is examined for bleeding Hematoma and ecchymosis are evaluated.for 24 hours. Another method is to remove the arterial sheet: The manual method is to remove the sheet, which is the usual method of removing the sheet, which is similar to the previous method. To ensure the absence of bleeding, the hand pressure is removed and the patient is examined for hematoma bleeding and ecchymosis for 24 hours. The primary variables hemorrhage. Timepoint: The initial outcome of bleeding is assessed immediately after the sheet is removed; 15 minutes later; 30 minutes later; 45 minutes later; 1 hour later; 2 hours later; 4 hours later: 8 hours later: 12 hours later; 24 hours later.In total, it is examined in 10 steps. Method of measurement: Measurement of bleeding volume is checked with a DM3 digital scale with an error level of 0.01 mg. Primary outcome of hematoma. Timepoint: The initial outcome of hematoma is assessed immediately after the sheet is removed; 15 minutes later; 30 minutes later; 45 minutes later; 1 hour later; 2 hours later; 4 hours later: 8 hours later: 12 hours later; 24 hours later.In total, it is examined in 10 steps. Method of measurement: Hematoma outcome is measured by calculating the area of ​​the hardened area by hand with using a standard transparent ruler. Primary outcome of vascular ecchymosis. Timepoint: The initial outcome of ecchymosis is assessed immediately after the sheet is removed; 15 minutes later; 30 minutes later; 45 minutes later; 1 hour later; 2 hours later; 4 hours later: 8 hours later: 12 hours later; 24 hours later.In total, it is examined in 10 steps. Method of measurement: The outcome of ecchymosis is measured by calculating the area of ​​skin discoloration to bruising without stiffness when touched by hand using a standard transparent ruler. Shahid Dr. Chamran Cardiovascular Research Institute, Isfahan Vice Chancellor for Research, Isfahan School of Nursing and Midwifery Isfahan University of Medical Sciences Shahid Dr. Chamran Cardiovascular Research Institute, Isfahan Vice Chancellor for Research, Isfahan School of Nursing and Midwifery Approved 2021-10-30 Ethics committee of Isfahan University of Medical Sciences Hezar Jerib St., Isfahan University of Medical Sciences, School of Nursing, Management and Rehabilitation Esfahan Isfehan Iran (Islamic Republic of)