Influence of the Compression Method After Transradial Catheterization in Radial Artery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 274
- Locations
- 1
- Primary Endpoint
- Determination of radial artery occlusion after catheterization
Study Overview
Brief Summary
The aim of the study is to determine differences on radial artery occlusion from two compressive methods used after transradial catheterization and its functional impact on hand mobility.
Detailed Description
Changes in Allen's test and pulse oximetry will be evaluated at baseline, 1 week and 3 month of catheterization in both groups of patients in order to check the functionality of the communications between the ulnar and radial arteries. The repercussion of each compressive method on radial occlusion and artery revascularization will be assessed by eco-Doppler at any time. Changes in diameter of arterial lumen of radial and ulnar arteries as a consequence of radial occlusion will be done simultaneously of blood flow Doppler measurements. The possible impact of radial occlusion on hand mobility will be done using a dynamometer designed to evaluate strength (Endurance test) and muscular claudication (Rapid exchange test).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients in whom at least the diagnostic catheterization has been done successfully by the radial artery route.
- •Patients with a negative Allen's Clinical test showing hyperemia before 9 seconds after pressure release over the ulnar artery pulse.
- •Patients showing a Barbeau pattern A,B or C with the pulsioximetric test after releasing pressure over the ulnar artery pulse.
- •Patients that will be able to do the follow up visits at 1 week and 3 month.
- •Signature of informed consent
Exclusion Criteria
- •Patients in that neither the diagnostic or therapeutic procedure has successfully done via the radial artery route.
- •Patients with a positive Allen's test (no hyperemia) after pressure and release over the ulnar artery pulse.
- •Patients showing a Barbeau pattern D with the pulsioximetric test after releasing pressure over the ulnar artery pulse.
- •Inability to visit at 1 week and 3 month.
- •Impossibility to obtain informed consent form
Arms & Interventions
Terumo
Patients in this arm will receive Terumo after catheterization
Intervention: Terumo (Other)
Tensoplast
Patients in this arm will receive Tensoplast after catheterization
Intervention: Tensoplast (Other)
Outcomes
Primary Outcomes
Determination of radial artery occlusion after catheterization
Time Frame: 3 month
Determination of radial artery occlusion at baseline (before catheterization), 1 week and 3 month after angiography/angioplasty in both compressive methods
Determination of radial artery occlusion at baseline (before catheterization)
Time Frame: 1 day
Determination of radial artery occlusion at baseline (before catheterization), 1 week and 3 month after angiography/angioplasty in both compressive methods
Determination of radial artery occlusion after catheterization
Time Frame: 1 week
Determination of radial artery occlusion at baseline (before catheterization), 1 week and 3 month after angiography/angioplasty in both compressive methods
Secondary Outcomes
- Anatomic differences in radial and ulnar diameters(3 month)
- Differences in functional status between occluded radial cohort and patent radial cohort(3 month)
- Differences in functional status at follow between compression groups(3 month)
- Differences in radial and ulnar blood flow between compression methods(3 month)
- Differences in functional status at follow between compression groups(1 day)
- Differences in functional status at follow between compression groups(1 week)
- Differences in functional status between occluded radial cohort and patent radial cohort(1 day)
- Differences in functional status between occluded radial cohort and patent radial cohort(1 week)