Femoral Arterial Access With Ultrasound Trial (FAUST)

This study has been completed.
Sponsor:
Collaborators:
C. R. Bard
University of Oklahoma
Long Beach Memorial Medical Center
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00667381
First received: April 24, 2008
Last updated: October 19, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention
Vascular Access Complications
Cardiac Catheterization
Peripheral Vascular Disease
Device: Real-time Ultrasound Guidance (Site-Rite 5 or 6 machine)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Femoral Arterial Access With Ultrasound Trial

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography [ Time Frame: Immediately, during procedure. ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Time to Successful Sheath Insertion. [ Time Frame: Immediate ] [ Designated as safety issue: No ]

    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.


  • Number of Patients With Accidental Femoral Venipunctures. [ Time Frame: Immediate ] [ Designated as safety issue: Yes ]

    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.


  • Number of Participants With Vascular Complications [ Time Frame: Immediate and up to 1 month after procedure. ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 1014
Study Start Date: April 2008
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Site-Rite 5 or 6 ultrasound 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667381

Locations
United States, California
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
University of California, Irvine Medical Center
Orange, California, United States, 92868
United States, Oklahoma
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
Oklahoma City VA Medical Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of California, Irvine
C. R. Bard
University of Oklahoma
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
  More Information

Publications:
Responsible Party: Arnold Seto, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00667381     History of Changes
Other Study ID Numbers: HS# 2007-5989
Study First Received: April 24, 2008
Results First Received: September 27, 2010
Last Updated: October 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Ultrasound guidance
Vascular access
Vascular complications

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 18, 2014