Clinical trial NCT00667381: Femoral Arterial Access With Ultrasound Trial
Official title: Femoral Arterial Access With Ultrasound Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Access Complications
Cardiac Catheterization
Peripheral Vascular Disease
Keywords: Ultrasound guidance
Vascular access
Vascular complications
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: C. R. Bard
name: University of Oklahoma
name: US Department of Veterans Affairs
name: Long Beach Memorial Medical Center
First posted: 2008-04-28
Enrollment: 1014
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography
timeFrame: Immediately, during procedure.
Secondary outcomes:
measure: Time to Successful Sheath Insertion.
timeFrame: Immediate
measure: Number of Patients With Accidental Femoral Venipunctures.
timeFrame: Immediate
measure: Number of Participants With Vascular Complications
timeFrame: Immediate and up to 1 month after procedure.
Other outcomes:
measure: Number of Patients With Successful Common Femoral Artery Placement, Among Those Patients With High Femoral Artery Bifurcations
timeFrame: At angiogram analysis
Locations:
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: Oklahoma City
country: United States
facility: Oklahoma City VA Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma University Medical Center
state: Oklahoma
Study officials:
affiliation: University of California, Irvine
name: Arnold H Seto, MD, MPA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Irvine
name: Morton Kern, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oklahoma Veteran's Administration Medical Center
name: Mazen Abu-Fadel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.