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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound |
| ||
| Fluoroscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arterial cannulation by angiographic imaging | Procedure | comparing successful arterial cannulation in case of non-cardiac vascular patient population. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of successful arterial cannulation by ultrasound and by fluoroscopy i.e. between two groups. | within 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of attempts, accidental venipunctures, first pass success, complications for arterial cannulation by ultrasound and by fluoroscopy i.e. between two groups. | within 30 to 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Stone, M.D. | CAMC Medical Staff-with admitting privileges | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vascular Center of Excellence | Charleston | West Virginia | 25304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31980242 | Result | Stone P, Campbell J, Thompson S, Walker J. A prospective, randomized study comparing ultrasound versus fluoroscopic guided femoral arterial access in noncardiac vascular patients. J Vasc Surg. 2020 Jul;72(1):259-267. doi: 10.1016/j.jvs.2019.09.051. Epub 2020 Jan 21. |
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