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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by CAMC Health System.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Patrick Stone, MD, CAMC Health System
ClinicalTrials.gov Identifier:
NCT01612026
First received: May 23, 2012
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Arterial Cannulation During Vascular Procedures
Procedure: arterial cannulation by angiographic imaging
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Ultrasound Versus Fluoroscopically-guided Arterial Access in Non-cardiac Vascular Patients

Resource links provided by NLM:


Further study details as provided by CAMC Health System:

Primary Outcome Measures:
  • Number of successful arterial cannulation by ultrasound and by fluoroscopy i.e. between two groups. [ Time Frame: within 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of attempts, accidental venipunctures, first pass success, complications for arterial cannulation by ultrasound and by fluoroscopy i.e. between two groups. [ Time Frame: within 30 to 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 1052
Study Start Date: May 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ultrasound Procedure: arterial cannulation by angiographic imaging
comparing successful arterial cannulation in case of non-cardiac vascular patient population.
Fluoroscopy Procedure: arterial cannulation by angiographic imaging
comparing successful arterial cannulation in case of non-cardiac vascular patient population.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01612026

Locations
United States, West Virginia
Vascular Center of Excellence
Charleston, West Virginia, United States, 25304
Sponsors and Collaborators
CAMC Health System
Investigators
Principal Investigator: Patrick Stone, M.D. CAMC Medical Staff-with admitting privileges
  More Information

No publications provided

Responsible Party: Patrick Stone, MD, Study Principal Investigator, CAMC Health System
ClinicalTrials.gov Identifier: NCT01612026     History of Changes
Other Study ID Numbers: 1997155
Study First Received: May 23, 2012
Last Updated: June 4, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 20, 2014