Ultrasound-guided In-plane Puncture of the Femoral Artery

Study Overview
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Brief Summary
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In Germany almost 1 million cardiac catheterizations are performed each year. These procedures can be done either by a transradial or a transfemoral approach. Today, the transradial approach is the recommended default strategy. Nevertheless, transfemoral access ist still frequently used. The main draw-back of a transfemoral approach are potential access site complications, which can sometimes be life-threatening. To reduce vascular complications ultrasound guided vessel puncture may be helpful. In the Ultrasound guided puncture of the femoral artery-Study (US-Parfem) an optimized method of ultrasound guided femoral puncture will be evaluated. In this randomized study the new puncture technique combining ultrasound and fluoroscopy will be compared with the conventional method guided by vessel palpation and fluoroscopy. Primary endpoint of the study is the rate of primary successful puncture of the femoral common artery above the bifurcation and below the inguinal ligament (first success rate).

Official Title
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Department of Cardiology Wuerzburg University

Conditions
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Vessel Puncture Site Bleeding

Intervention / Treatment
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* Other: Palpation and Fluoroscopy
* Procedure: Ultrasound guidance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: transfemoral catheterization Exclusion Criteria: acute myocardial infarction
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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound guidance<br> | Procedure: Ultrasound guidance<br>* Vessel puncture guided by Ultrasound<br>|
| Other: Palpation and Fluoroscopy<br> | Other: Palpation and Fluoroscopy<br>* Vessel puncture guided palpation and fluoroscopy only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial successful puncture of the common femoral artery | Analysis of rotational femoral angiography | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unsuccessful puncture attempts | number of unsuccessful puncture attempts | access-phase of the procedure | 
| Perception of pain | pain scale between 0 (no pain) and 10 (maximum pain) graded by the patient | Evaluated at the end of the access-phase of the procedure | 
| accidental venipuncture | Venipuncture was recognized by backflow of pulsatile and non-arterial blood | at the end of the access-phase of the procedure | 
| Duration until successful puncture | Time frame between start of initial puncture and successful introduction of the guide-wire up to 1 minute | Evaluated at the end of the access-phase of the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasound guided puncture