Femoral Arterial Access With Ultrasound Trial

University of California, Irvine1,014 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,014

Conditions

Vascular Access Complications Cardiac Catheterization Peripheral Vascular Disease

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

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

Outcomes

Primary Outcomes

Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography

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.

Time frame: Immediately, during procedure.

Secondary Outcomes

Time to Successful Sheath Insertion.

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.

Time frame: Immediate

Number of Patients With Accidental Femoral Venipunctures.

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.

Time frame: Immediate

Number of Participants With Vascular Complications

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.