Femoral Arterial Access With Ultrasound Trial - Full Text View

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 ultrasound machine)

MedlinePlus related topics:

Peripheral Vascular Diseases Ultrasound Vascular Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Official Title:	Femoral Arterial Access With Ultrasound Trial

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

Primary Outcome Measures:

Successful common femoral artery cannulation, as determined by femoral angiography. [ Time Frame: Immediately, during procedure. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time to successful sheath insertion. [ Time Frame: Immediate ] [ Designated as safety issue: No ]
Number of femoral venipunctures. [ Time Frame: Immediate ] [ Designated as safety issue: Yes ]
Vascular complications, including bleeding, thrombosis, dissection, transfusion. [ Time Frame: Immediate and up to 1 month after procedure. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1000
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Control: No Intervention The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
Ultrasound: Experimental 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 ultrasound 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.

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

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

Contacts


Contact: Arnold Seto, MD, MPA	714-506-7464	aseto@uci.edu

Contact: Mazen Abu-Fadel, MD	405-620-8043	mazen-abufadel@ouhsc.edu

Locations


United States, California
	University of California, Irvine Medical Center	Recruiting
	Orange, California, United States, 92868
	Contact: Arnold Seto, MD, MPA 714-506-7464 aseto@uci.edu
	Principal Investigator: Arnold Seto, MD, MPA
	Long Beach Memorial Medical Center	Recruiting
	Long Beach, California, United States, 90806
	Contact: Arnold Seto, MD, MPA 714-506-7464 aseto@uci.edu
	Principal Investigator: Rex Winters, MD

United States, Oklahoma
	Oklahoma University Medical Center	Recruiting
	Oklahoma City, Oklahoma, United States, 73104
	Contact: Mazen Abu-Fadel, MD 405-620-8043 mazen-abufadel@ouhsc.edu
	Principal Investigator: Mazen Abu-Fadel, MD
	Oklahoma City VA Medical Center	Recruiting
	Oklahoma City, Oklahoma, United States, 73104
	Contact: Mazen Abu-Fadel, MD 405-620-8043 mazen-abufadel@ouhsc.edu
	Principal Investigator: Mazen Abu-Fadel, MD

Sponsors and Collaborators

University of California, Irvine

C. R. Bard

University of Oklahoma

Department of Veterans Affairs

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

Responsible Party:	University of California, Irvine ( Arnold Seto )
Study ID Numbers:	HS# 2007-5989
First Received:	April 24, 2008
Last Updated:	April 25, 2008
ClinicalTrials.gov Identifier:	NCT00667381
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

Ultrasound guidance

Vascular access

Vascular complications

Study placed in the following topic categories:

Peripheral Vascular Diseases

Vascular Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 08, 2008

Sponsors and Collaborators:	University of California, Irvine C. R. Bard University of Oklahoma Department of Veterans Affairs Long Beach Memorial Medical Center
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00667381