Vessel Puncture Site Bleeding
Conditions
Keywords
ultrasound guided puncture
Brief summary
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).
Interventions
OTHERPalpation and Fluoroscopy
Vessel puncture guided palpation and fluoroscopy only
PROCEDUREUltrasound guidance
Vessel puncture guided by Ultrasound
Sponsors
Wuerzburg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* transfemoral catheterization
Exclusion criteria
* acute myocardial infarction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initial successful puncture of the common femoral artery | 1 week | Analysis of rotational femoral angiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unsuccessful puncture attempts | access-phase of the procedure | number of unsuccessful puncture attempts |
| Perception of pain | Evaluated at the end of the access-phase of the procedure | pain scale between 0 (no pain) and 10 (maximum pain) graded by the patient |
| accidental venipuncture | at the end of the access-phase of the procedure | Venipuncture was recognized by backflow of pulsatile and non-arterial blood |
| Duration until successful puncture | Evaluated at the end of the access-phase of the procedure | Time frame between start of initial puncture and successful introduction of the guide-wire up to 1 minute |
Countries
Germany
Outcome results
None listed