The Study On The Safety Of Sample Of The Patent "elastic Radial Artery Compression Hemostatic Device"

Objective:In this study,we transformed a patent radial artery compression hemostat,and evaluated the safety of the sample after the patent transformation,observing the differences in hemostatic effects,complications and subjective feelings of patients with TR Band which is widely used now,to provide early clinical data for further optimization of the hemostatic device and later large sample clinical trials,and also provide new ideas for future design and improvement of the compression device.Methods:In this study,random sampling was used to collect data from the First Hospital of Shanxi Medical University from June 2020 to February 2021 to prepare for coronary angiography（CAG）or percutaneous coronary intervention（PCI）via the radial artery in patients with 60 case.60 eligible participants were randomly divided into a test group and a control group,each with 30 people.Patients in the test group used a new elastic radial artery compression hemostatic device to stop bleeding at the puncture site.The control group used TR Band balloon compression hemostatic device to stop bleeding at the puncture site.Collect general data and special data of the two groups,and count the clinical data of the two groups in terms of hemostatic effect,local complications,related changes in the device,and discomfort of patients.Results:1.There was no statistically significant difference between the two groups of patients in indicators such as age,gender,wrist circumference,body mass index,past medical history,family history,smoking history,platelet count,blood coagulation,creatinine,and regular antiplatelet drugs（P>0.05）;There was no statistically significant difference between the two groups in blood pressure,heart rate,wrist circumference,type of surgery（P>0.05）.2.Both groups achieved effective hemostasis,and there was no inability to stop bleeding.There was no statistically significant difference between the two groups in bleeding,hematoma,ecchymosis,skin damage,and local infection（P>0.05）.3.In terms of subjective feelings,there was a statistically significant difference in pain between the two groups at 1h（before the first deflation）,6h,and 24h（P<0.05）;there was a statistically significant difference in the swelling between the two groups at 6h and24h after operation（P<0.05）;there was no statistically significant difference in numbness between the two groups at 1h（before the first deflation）,6h,and 24h after operation（P>0.05）.In terms of pain and swelling,the new radial artery hemostatic device is superior to the TR Band balloon hemostatic device.4.There was no significant difference in SPO₂ and wrist circumference between the two groups at different time points（P>0.05）;there was statistically significant difference in systolic blood pressure between the two groups at 1h（before the first deflation）、6h and24h（P<0.05）;the difference was statistically significant in the diastolic blood pressure of the two groups which compared 6h and 24h after operation with 0h（before the operation）（P<0.05）;the difference of the pulse at 1h（before the first deflation）、6h after operation was statistically significant with 0h（before the operation）in the two groups（P<0.05）.5.For the new hemostatic device group,there were statistically significant differences in SPO₂ and wrist circumference at 1h（before the first deflation）、6h、24h,compared with0h（before the operation）（P<0.05）;for the TR Band group,1h（before the first deflation）、6h SPO₂,1h（before the first deflation）、6h、24h wrist circumference measurement was statistically different from that 0h（before the operation）（P<0.05）;there was no significant difference in systolic blood pressure,diastolic blood pressure,and pulse between the hemostatic device group and the TR Band group at 1h（before the first deflation）,6h,and 24h after the operation compared with 0h（before the operation）（P>0.05）.Conclusion:The new elastic radial artery compression hemostatic device sample can achieve effective hemostasis at the puncture site after CAG or PCI.It is not inferior to the TR Band balloon hemostatic device in terms of safety and is superior to the TR Band balloon hemostatic device in terms of comfort.