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Radial approach is widely established in cardiac diagnostic and therapeutic treatments. It has been shown to decrease bleeding, vascular problems, and mortality rates when compared to the femoral approach. It also offers better comfort to patients through early mobility and lowers hospital expenses.
Previously, there were no specific devices for radial artery hemostasis. Many different types of dressings were used in various hospitals with no standardization. This raises the question of whether specific devices surpass dressings in terms of patient comfort, time required to maintain hemostasis, and vascular complications.
The primary goal of this study was to examine the effectiveness of compression dressings and hemostatic wristbands on patients undergoing cardiac procedures via radial approach in terms of patient comfort, time required to maintain hemostasis, and vascular problems.
The hemostatic wristband TR BandR (Terumo Corporation, Tokyo, Japan) was utilized in one group, while compressive elastic dressing, standardized as 13 threads gauze overlapped, opened, longitudinally pleated once and wrapped, making a 5-cm long cylinder, 1-cm in height, was used in the other.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compressive Elastic dressing | Experimental | Patients who received compressive elastic dressing as a hemostasis technique after coronary angiography using radial approach. |
|
| wristband TR Band | Active Comparator | Patients who received wristband TR Band as a hemostasis technique after coronary angiography using radial approach. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compressive Elastic dressing for hemostasis in cardiac procedure using radial approach | Procedure | Following cardiac procedure using radial approach, compressive elastic dressing, standardized as 13 threads gauze overlapped, opened, longitudinally pleated once and wrapped, making a 5-cm long cylinder, 1-cm in height, fixed with elastic crepe bandage was used to achieve hemostasis. |
| Measure | Description | Time Frame |
|---|---|---|
| Compression "hemostasis" time | The time from the placement of the hemostatic Wristband or Compressive dressing until its removal (when there's no blood oozing after removal), measured by minutes. | Up to 240 minutes after placement |
| Number of patient with Hematoma and Grade of hematoma | It is defined by EASY hematoma scale. | Within 24 hours after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patient with Radial artery occlusion | Radial artery patency was checked by evaluating radial pulse, capillary refill, hand color, temperature, and assessing the puncture site and hand for any hematoma or bleeding. In the event of an access site hematoma or any other ischemia sign, the patient will be sent to the radiology department for further assessment with radial artery Doppler. | Within 24 hours after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yunis A Daralammouri | An-Najah National University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| An-Najah National University Hospital | Nablus | West Bank | P4170051 | Palestinian Territories | ||
| An-Najah National University Hospital |
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Patients enrolled to the study were randomized into TR Band or compressive dressing groups. Care providers operated on patients and investigators collected their data during and after the operation. The independent variable - Hemostasis technique (TR Band or compressive dressing ) - was coded into X or Z groups, then data was sent to the outcomes assessor.
|
| Wristband TR band for hemostasis in cardiac procedure using radial approach | Procedure | Following cardiac procedure using radial approach, hemostatic wristband TR BandR (Terumo Corporation, Tokyo, Japan) was utilized was used to achieve hemostasis. |
|
| Ischemic changes to the hand | It is noted by clinical features of pallor, absence of pulse, pain, cold, paresthesia or paralysis. | Within 24 hours after the procedure |
| Post-procedural pain | Assessed by numerical rating scale (NRS) for pain, which is an 11 point subjective scale (0-10) where 0 refers for no pain, 1-3 for mild pain, 4-6 for moderate pain and 7-10 for severe pain. | Within 24 hours after the procedure |
| Number of patient with Radial Artery Occlusion on follow up | Radial artery patency was checked by evaluating radial pulse and Doppler Ultrasonography. | After 4 weeks of the procedure. |
| Patient satisfaction of the used compression methode Assessed by Likert scale for satisfaction | Assessed by Likert scale for satisfaction , which is a 5 point subjective scale (1-5) where 1 refers for Not at all satisfied , 2 for slightly satisfied , 3 for moderately satisfied, 4 for Very satisfied and 5 for Extremely satisfied. | Within 24 hrs |
| Nablus |
| Palestinian Territories |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D009203 | Myocardial Infarction |
| D000789 | Angina, Unstable |
| D060050 | Angina, Stable |
| D054058 | Acute Coronary Syndrome |
| D000072657 | ST Elevation Myocardial Infarction |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D050197 | Atherosclerosis |
| D002637 | Chest Pain |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000787 | Angina Pectoris |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D006487 | Hemostasis |
| ID | Term |
|---|---|
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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