Ultrasound Versus Fluoroscopically-guided Arterial Access in Non-cardiac Vascular Patients

Completed

• Conditions: Arterial Cannulation During Vascular Procedures
• Interventions: Procedure: arterial cannulation by angiographic imaging

• Registration Number: NCT01612026
• Lead Sponsor: CAMC Health System

Brief 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.

Study Timeline

• Study First Submitted: 2012-05-23
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-05
• Study Start: 2013-03
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2019-05
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 643

Inclusion Criteria

• Patients greater than 18 years of age undergoing a non-cardiac catheter-based diagnostic or interventional procedure requiring femoral artery cannulation. This will include patients with co-morbid conditions of coronary artery disease and other cardiac health problems.

Exclusion Criteria

1. Patients less than 18 years of age.
2. Patients enrolled in another IRB approved biomedical study.
3. Pregnant females.
4. Prisoners.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ultrasound	arterial cannulation by angiographic imaging	-
Fluoroscopy	arterial cannulation by angiographic imaging	-

Primary Outcome Measures

Name	Time	Method
Number of successful arterial cannulation by ultrasound and by fluoroscopy i.e. between two groups.	within 30 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Vascular Center of Excellence; 🇺🇸 Charleston, West Virginia, United States