Ultrasound Versus Fluoroscopically-guided Arterial Access in Non-cardiac Vascular Patients
Condition: Arterial Cannulation During Vascular Procedures
Study type: Observational

Summary: 
      In the investigators vascular practice, either fluoroscopic- or ultrasound-guided technique
      is routinely used to obtain femoral arterial access. Ultrasound-guidance is frequently used
      in patients with weak or absent pulses, known abnormal vascular anatomy, need for bypass
      graft puncture, and to ensure accurate arterial puncture in patients expected to receive
      large doses of blood-thinning medications during or after the procedure. For those
      practitioners experienced with ultrasound-guided access techniques, it is considered highly
      accurate and easy to use; thus, some physicians routinely use this tool. A well-designed
      study is needed to truly assess the accuracy of the ultrasound technique and to determine
      whether it may reduce complications of arterial access in vascular patients.

      By demonstrating the safest, most accurate and efficient technique for obtaining arterial
      access during catheter-based procedures, the investigators could significantly reduce
      morbidity and mortality associated with complications of arterial puncture. Length of
      hospital stay, management costs and patient discomfort could be reduced by minimizing
      complication rates.
    

Detailed description: 
      Arterial access accounts for the highest frequency of complications in catheter-based
      procedures in the U.S. In our vascular practice, ultrasound-guidance is frequently used in
      patients with weak or absent pulses, known aberrant vascular anatomy, need for graft
      puncture, and to ensure accurate arterial puncture in patients expected to receive large
      doses of anti-thrombotic medications. Some practitioners routinely use this modality. The
      purpose of this study is to determine whether real-time ultrasound guidance is superior to
      fluoroscopic guidance in obtaining successful arterial cannulation during diagnostic and
      interventional catheter-based procedures in a primarily non-cardiac vascular patient
      population. Patients will be randomized to receive either real-time ultrasound-guided
      arterial access or fluoroscopic-guided access. Baseline patient demographics, co-morbidities,
      medications, pertinent laboratory data, and indications for procedure will be recorded.
      Procedural data recorded will include procedure type, type of access, operator, pulse
      quality, sheath size, closure device, angiographic data for access artery, antithrombotic
      medications used, and intra-procedural activated clotting times. Primary endpoint will be
      successful arterial cannulation by angiographic imaging. Secondary end points will be time to
      access, number of attempts, accidental venipunctures, first pass success, complication rates
      and hospital length of stay. Data regarding complications (patient history, examination,
      laboratory or imaging studies) will be included for a period of 90 days after the procedure.
    

Intervention name(s): arterial cannulation by angiographic imaging
Intervention type(s): Procedure
Intervention description(s): comparing successful arterial cannulation in case of non-cardiac vascular patient population.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects referred to the West Virginia University Department of Surgery: Division of
        Vascular and Endovascular Surgery with accepted indications to undergo a catheter-based
        diagnostic or interventional procedure requiring arterial cannulation.Procedures include
        peripheral, renal, mesenteric and carotid.