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The investigators are conducting a randomized clinical trial, having as a primary objective, to compare vascular access time between distal and proximal radial approach. Secondary objectives include comparing incidence of distal and proximal radial artery occlusion, at 24 hrs and 30 days. As a tertiary objective investigators will compare the preference of the patients for each access in subsecuent interventional procedures.
Randomised Clinical Trial / Equivalence Model Permutted block asignation 1:1 Statistical Power 90% and Significance 2.5%. Sample Loss estimation - 15% Chi-square to categorical and T Student to numerical variables. Logistic regression binomial for adverse outcomes. If needed, an intention to treat analysis will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Distal Radial Access | Experimental | Distal Radial (Anatomical Snuffbox) Vascular Access prior to catheterization |
|
| Proximal Radial Access | Active Comparator | Proximal Radial Vascular Access prior to catheterization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Distal Radial Vascular Access | Procedure | Distal Radial Vascular Access |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vascular Access Time | Starts when the anesthesia needle contacts the skin and stops when the introducer sheath has been properly placed and flushed. | Seconds during the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| "Conventional" Radial Artery Occlusion | Radial Artery Occlusion using vascular ultrasound | In the first 24 hours, and follow up to 30 days |
| Distal Radial Artery Occlusion | Distal Radial Artery Occlusion using vascular ultrasound |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life outcome | Patient preference for the same access in case a second procedure is needed | 30-day survey |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Mexicano del Seguro Social | Tijuana | Estado de Baja California | 22226 | Mexico |
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(planned) March 2022
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D001157 | Arterial Occlusive Diseases |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Randomised Clinical Trial - Equivalence model (Two tailed) Based on a previous pilot study: SD 97 sec Allowable Diff: 90 sec, Patient loss 15%, Type I error 2.5%, Type II error 90% Mean Differences: 0
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| In the first 24 hours, and follow up to 30 days |
| D001161 |
| Arteriosclerosis |
| D014652 | Vascular Diseases |