Prevention of Radial Artery Occlusion After Trans-radial Cardiac Catheterization

Study Overview
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Brief Summary
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Data from literature: transradial access failure sometimes occurs due to inability to cannulate the radial artery due to radial artery spasm1 causing severe difficulties in manipulation of the guide wires and catheters along the tortuous pathways of the arteries. both mechanical stimuli and circulating catecholamines through activation of α1-adrenoreceptors, causing smooth muscle cell contraction & radial artery spasm

Official Title
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Prevention of Radial Artery Occlusion After Trans-radial Cardiac Catheterization. Randomized Duplex Follow-up Study.

Conditions
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CARDIAC CATHETRIZATION

Intervention / Treatment
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* Device: ulnar artery compression device
* Device: radial artery compression device guided with plysthmography
* Device: radial artery compression device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal radial artery and of size ≥ 2mm by duplex. Normal ulnar artery by duplex. Exclusion Criteria: Pre-procedural duplex detection of radial artery anomalies as hypoplasia, tortousity, severe calcification or radial artery diameter < 2 mm. Severe renal failure (creatinine clearance < 30 ml/min). Known peripheral vascular disease. Emergency procedures. Failure to successfully cannulate the radial artery was also a criterion for exclusion. Patients on warfarin therapy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ULTRA method group<br> | Device: ulnar artery compression device<br>* a radial compression device will be applied at the access site. another closure device will be used for ipsilateral ulnar artery compression for 1-hour duration in order to increase peak velocity blood flow into the radi¬al artery. neither pulse oxymetry nor duplex ultrasonography will be performed in case of ulnar artery compression. after ulnar artery compression, the initial compression of the radial artery will be reduced by letting up the pressure until bleeding will be seen and then adding minimal pressure whenever needed in order to maintain radial artery patency.<br>Device: radial artery compression device<br>* patients undergo the conventional hemostasis compression by using a radial compression device applied at the access site.<br>|
| Active Comparator: standard patent hemostasis group<br> | Device: radial artery compression device guided with plysthmography<br>* a radial compression device will be applied at the access site. A pulse oximeter sensor was placed over the index finger. Transient ipsilateral ulnar artery will be occluded manually to evaluate the status of radial artery patency by plethysmography (digital pulse analysis), and if there's lack of signal, the process of deflation and reinflation of the radial artery device's bladder will be repeated over the next 15 min to attempt re-establishment of antegrade radial artery flow without affecting hemostasis<br>|
| Experimental: control group<br> | Device: radial artery compression device<br>* patients undergo the conventional hemostasis compression by using a radial compression device applied at the access site.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of occurrence of radial artery occlusion | the assessment will be done after compression device removal guided by duplex post trans-radial cardiac catheterization. | 1 hour |