Femoral Arterial Access With Ultrasound Trial

Not Applicable

Completed

Conditions: Vascular Access Complications
Cardiac Catheterization
Peripheral Vascular Disease

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

Registration Number: NCT00667381

Lead Sponsor: University of California, Irvine

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1014

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound	Real-time Ultrasound Guidance (Site-Rite 5 or 6 machine)	Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.

Primary Outcome Measures

Name	Time	Method
Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography	Immediately, during procedure.	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

Name	Time	Method
Time to Successful Sheath Insertion.	Immediate	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.	Immediate	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	Immediate and up to 1 month after procedure.	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.

Trial Locations

Locations (4): Long Beach Memorial Medical Center
🇺🇸
Long Beach, California, United States
Oklahoma University Medical Center
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Oklahoma City, Oklahoma, United States
University of California, Irvine Medical Center
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Orange, California, United States
Oklahoma City VA Medical Center
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Oklahoma City, Oklahoma, United States