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

NCT ID: NCT01612026

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 643 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2017-10-31

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.

Conditions

Arterial Cannulation During Vascular Procedures

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Ultrasound

arterial cannulation by angiographic imaging

Intervention Type: PROCEDURE

comparing successful arterial cannulation in case of non-cardiac vascular patient population.

Fluoroscopy

arterial cannulation by angiographic imaging

Intervention Type: PROCEDURE

comparing successful arterial cannulation in case of non-cardiac vascular patient population.

Interventions

arterial cannulation by angiographic imaging

comparing successful arterial cannulation in case of non-cardiac vascular patient population.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CAMC Health System

OTHER

Sponsor Role: lead

Responsible Party

Patrick Stone, MD

Study Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick Stone, M.D.

Role: PRINCIPAL_INVESTIGATOR

CAMC Medical Staff-with admitting privileges

Locations

Vascular Center of Excellence

Charleston, West Virginia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 31980242 (View on PubMed)

Other Identifiers

1997155

Identifier Type: -

Identifier Source: org_study_id