Femoral Arterial Access With Ultrasound Trial (FAUST)

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Vascular Disease; Cardiac Catheterization; Vascular Access Complications
• Intervention / Treatment: Device: Real-time Ultrasound Guidance (Site-Rite 5 or 6 machine)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 1014
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90806
      • Long Beach Memorial Medical Center
    • Orange, California, United States, 92868
      • University of California, Irvine Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma University Medical Center
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma City VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
EXPERIMENTAL: Ultrasound; Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.	Device: Real-time Ultrasound Guidance (Site-Rite 5 or 6 machine); Real-time ultrasound guidance will be used to aid in femoral artery cannulation. This will occur with a 7 MHz ultrasound probe covered with a sterile cover.; Other Names: Site-Rite 5 or 6 ultrasound machine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography	Femoral angiography was performed in 490 control patients and 499 ultrasound patients. In 11 control and 4 ultrasound patients, femoral angiography was either not performed or was inadequate for analysis. These patients were excluded from the primary outcome analysis but included for other analyses. Successful common femoral artery cannulation was defined as sheath insertion above the bifurcation of the common femoral artery and below the origin of the inferior epigastric artery. Unsuccessful sheath insertion was defined as sheath insertion outside of these markers.	Immediately, during procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Successful Sheath Insertion.	Time was measured from first fluoroscopy of the femoral head (control group), or first application of the ultrasound probe (ultrasound group), until successful sheath insertion. Time was not recorded for 1 control patient, and 1 ultrasound patient, these patients were excluded from this analysis but included for other analyses.	Immediate
Number of Patients With Accidental Femoral Venipunctures.	Number of patients with any femoral venipunctures where an insertion was not intended, i.e. excluding patients with planned right heart catheterization. Multiple accidental venipunctures were not double counted. Number of attempts and venipunctures were not recorded in 1 control and 1 ultrasound patient, so the denominator is 500 control patients and 502 ultrasound patients.	Immediate
Number of Participants With Vascular Complications	Vascular complications were defined as vessel thrombosis, dissection, blood transfusion, hematoma > 5cm diameter, unexplained bleeding with a drop in Hgb >4 g/dL, or access site bleeding with drop in Hgb >3 g/dL. Outcome was assessed by chart review, and clinical or telephone followup at 30 days. Medical records were adjudicated by a blinded independent review committee.	Immediate and up to 1 month after procedure.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Successful Common Femoral Artery Placement, Among Those Patients With High Femoral Artery Bifurcations	Patients found to have femoral artery bifurcations occurring over the femoral head were prospectively defined as having a high femoral bifurcation. This subgroup was prespecified for analysis during the trial designed, as it was suspected that operators would have particular difficulty inserting the sheath accurately in this population.	At angiogram analysis

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: University of Oklahoma; US Department of Veterans Affairs; C. R. Bard; Long Beach Memorial Medical Center
• Investigators: Principal Investigator: Arnold H Seto, MD, MPA, University of California, Irvine; Principal Investigator: Morton Kern, MD, University of California, Irvine; Principal Investigator: Mazen Abu-Fadel, MD, Oklahoma Veteran's Administration Medical Center

Publications and helpful links

General Publications

• Seto AH, Abu-Fadel MS, Sparling JM, Zacharias SJ, Daly TS, Harrison AT, Suh WM, Vera JA, Aston CE, Winters RJ, Patel PM, Hennebry TA, Kern MJ. Real-time ultrasound guidance facilitates femoral arterial access and reduces vascular complications: FAUST (Femoral Arterial Access With Ultrasound Trial). JACC Cardiovasc Interv. 2010 Jul;3(7):751-8. doi: 10.1016/j.jcin.2010.04.015.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (ACTUAL): February 1, 2009
• Study Completion (ACTUAL): March 1, 2009

Study Registration Dates

• First Submitted: April 24, 2008
• First Submitted That Met QC Criteria: April 25, 2008
• First Posted (ESTIMATE): April 28, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): November 16, 2010
• Last Update Submitted That Met QC Criteria: October 19, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Ultrasound guidance; Vascular access; Vascular complications
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: HS# 2007-5989