Femoral Arterial Access With Ultrasound Trial

NCT ID: NCT00667381

Last Updated: 2010-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1014 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-03-31

Brief Summary

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.

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.

Conditions

Vascular Access Complications; Cardiac Catheterization; Peripheral Vascular Disease

Keywords

Ultrasound guidance; Vascular access; Vascular complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Ultrasound

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Site-Rite 5 or 6 ultrasound machine.

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

Long Beach Memorial Medical Center

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

University of California, Irvine

Principal Investigators

Arnold H Seto, MD, MPA

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Morton Kern, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Mazen Abu-Fadel, MD

Role: PRINCIPAL_INVESTIGATOR

Oklahoma Veteran's Administration Medical Center

Locations

Long Beach Memorial Medical Center

Long Beach, California, United States

University of California, Irvine Medical Center

Orange, California, United States

Oklahoma City VA Medical Center

Oklahoma City, Oklahoma, United States

Oklahoma University Medical Center

Oklahoma City, Oklahoma, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20650437 (View on PubMed)

Other Identifiers

HS# 2007-5989

Identifier Type: -

Identifier Source: org_study_id