Femoral Arterial Access With Ultrasound Trial (FAUST)

University of California Irvine (UCI)

Status: Completed

Conditions: Cardiac Catheterization; Peripheral Vascular Disease; Vascular Access Complications

Treatments: Device: Real-time Ultrasound Guidance (Site-Rite 5 or 6 machine)

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT00667381

HS# 2007-5989

Details and patient eligibility

About

This study is designed to evaluate the routine use of vascular ultrasound as an aid for proper placement of a femoral arterial sheath during cardiac catheterization and peripheral arterial angiography.

Full description

Cardiac catheterization is conventionally performed with femoral arterial access using a combination of arterial pulse palpation, anatomical landmarks, and fluoroscopic landmarks to guide needle insertion. Vascular access complications including hematoma formation, retroperitoneal bleeding, and arterial dissection are the most common types of adverse events associated with cardiac catheterization, and have been associated with insertions above and below the level of the common femoral artery. Real-time ultrasound assistance for central venous catheter placement has been proven in multiple studies to reduce complications, and has been recommended by the Agency for Healthcare Research and Quality as a "Top 11 Highly Proven" patient safety practice. This recommendation has not yet been extended to arterial access, due to a lack of studies to date. However, ultrasound assistance is licensed for and commonly utilized for arterial access, especially in difficult patients.

In a pilot study of 71 procedures performed by the lead researcher, ultrasound guidance was associated with an improved 1st pass success rate (83% vs 47%, p=0.002), reduced risk of accidental venipunctures (0% vs 25%, p=0.002), and greater overall success in common femoral artery cannulation (89% vs 69%, p=0.048) as compared with the fluoroscopic control.

This study is a multicenter prospective randomized trial to generalize the above findings with more patients studied, a larger number of operators, and across several centers. Similar to the previous study, the ultrasound will be used real-time to visualize the femoral vein, femoral artery, and needle tract as the needle is inserted, to guide the needle towards the appropriate location in the artery. The time for insertion, number of passes, complications, and position of the insertion catheter on the femoral angiogram will be analyzed in the setting of patient factors including age, body mass index, and presence of peripheral vascular disease.

Enrollment: 1,014 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults age 18 and over
• Patients undergoing left heart catheterization or peripheral arterial angiography from the retrograde femoral approach
• Willingness and ability to sign consent form
• Scheduled to have procedure performed by operator trained in the ultrasound technique

Exclusion criteria

• Access from a site other than the common femoral artery
• Nonpalpable femoral pulses
• Creatinine > 3.0 mg/dl, unless already on dialysis
• Prisoners
• Pregnant women
• Unable or refusal to sign consent form
• Patients undergoing emergent cardiac catheterization for ST segment elevation myocardial infarction or unstable acute coronary syndrome
• Equipment unavailable

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,014 participants in 2 patient groups

Control

No Intervention group

Description:

The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.

Ultrasound

Experimental group

Description:

Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.

Treatment:

Device: Real-time Ultrasound Guidance (Site-Rite 5 or 6 machine)