Ultrasound-guided In-plane Puncture of the Femoral Artery

Not Applicable

Completed

• Conditions: Vessel Puncture Site Bleeding
• Interventions: Procedure: Ultrasound guidance; Other: Palpation and Fluoroscopy

• Registration Number: NCT06065943
• Lead Sponsor: Wuerzburg University Hospital

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").

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2023-09-05
• Study First Submitted QC: 2023-09-26
• Study First Posted: 2023-10-04
• Primary Completion: 2024-03-31
• Study Completion: 2024-06-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

• transfemoral catheterization

Exclusion Criteria

• acute myocardial infarction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound guidance	Ultrasound guidance	-
Palpation and Fluoroscopy	Palpation and Fluoroscopy	-

Primary Outcome Measures

Name	Time	Method
Initial successful puncture of the common femoral artery	1 week	Analysis of rotational femoral angiography

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital; 🇩🇪 Würzburg, Germany