Acute Coronary Syndrome, Angina, Stable, Angina, Unstable, Atherosclerotic Cardiovascular Disease, Chest Pain, Coronary Artery Disease, Ischemic Heart Disease, Myocardial Infarction, Non ST Elevation Myocardial Infarction, NSTEMI, STEMI
Conditions
Keywords
Radial approach, Wristband, TR Band, compressive dressing, cardiac catheterization, radial artery, safeguard, randomized controlled trial
Brief summary
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.
Interventions
PROCEDURECompressive Elastic dressing for hemostasis in cardiac procedure using radial approach
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.
PROCEDUREWristband TR band for hemostasis in cardiac procedure using radial approach
Following cardiac procedure using radial approach, hemostatic wristband TR BandR (Terumo Corporation, Tokyo, Japan) was utilized was used to achieve hemostasis.
Sponsors
An-Najah National University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Patients who agree to participate in the study and sign the consent form. * Patients with an indication for coronary catheterization * Clinically stable patients * Patients with palpable pulses on at least one of the radial arteries.
Exclusion criteria
* Patients who are hemodynamically unstable (systolic blood pressure less 90mmhg) * Patients with radial AV shunt for hemodialysis * Patients with previous CABG using radial artery * Patients with Renaud phenomenon or lymphedema * Patients who had vascular problems at the puncture site before the hemostasis process started. * Failure to obtain radial access
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compression hemostasis time | Up to 240 minutes after placement | 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. |
| Number of patient with Hematoma and Grade of hematoma | Within 24 hours after the procedure | It is defined by EASY hematoma scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-procedural pain | Within 24 hours after the procedure | 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. |
| Number of patient with Radial artery occlusion | Within 24 hours after the procedure | 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. |
| Patient satisfaction of the used compression methode Assessed by Likert scale for satisfaction | Within 24 hrs | 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. |
| Number of patient with Radial Artery Occlusion on follow up | After 4 weeks of the procedure. | Radial artery patency was checked by evaluating radial pulse and Doppler Ultrasonography. |
| Ischemic changes to the hand | Within 24 hours after the procedure | It is noted by clinical features of pallor, absence of pulse, pain, cold, paresthesia or paralysis. |
Countries
Palestinian Territories
Outcome results
None listed