Radial Artery Access With Ultrasound Trial

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Palpation; Procedure: Ultrasound guidance

• Registration Number: NCT01605292
• Lead Sponsor: University of California, Irvine

Brief Summary

Radial artery access for cardiac catheterization can require multiple attempts. Multiple attempts increase the time required, patient discomfort, and the risk of arterial spasm. Ultrasound guidance has been shown in other studies to reduce the number of attempts and complications in central venous and femoral artery access. This study will test if the addition of ultrasound guidance reduces the number of attempts and time required to access the radial artery.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-26
• Study First Submitted QC: 2012-05-22
• Study First Posted: 2012-05-24
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2014-12-29
• Status Verified: 2015-02
• Results First Submitted QC: 2015-02-25
• Last Update Submitted: 2015-02-25
• Results First Posted: 2015-02-26
• Last Update Posted: 2015-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 698

Inclusion Criteria

• Adult patients presenting for cardiac or peripheral catheterization with planned radial approach.
• Barbeau's or Allen's test indicating at least some degree of collateral circulation in palmar vessels
• Functional ultrasound equipment with ultrasound trained attending operator

Exclusion Criteria

• Inability to provide informed consent
• Femoral access
• Emergency procedure (Shock, STEMI)
• End-stage renal disease on hemodialysis
• Previous ipsilateral puncture within 1 week

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Palpation	Palpation	Manual palpation of radial pulse, as sole guide to needle cannulation.
Ultrasound	Ultrasound guidance	Real-time ultrasound guidance to facilitate needle cannulation of artery.

Primary Outcome Measures

Name	Time	Method
Number of Attempts	Immediately during procedure. (up to 30 minutes)	Number of passes of the needle required to access the artery during the cardiac catheterization procedure. This is only assessed at the time of the procedure, i.e. during the first 30 minutes. This is to be reported as both total number of attempts and as a first pass success rate.

Secondary Outcome Measures

Name	Time	Method
Time to Sheath Insertion (Seconds)	Immediately during procedure (within 30 minutes)	Time from initiation of vascular access attempts to successful aspiration or flushing of the sheath. Time for lidocaine administration, palpation of pulse, or imaging is excluded.
First-pass Success Rate	Immediate	Proportion of procedures achieving access on the first attempt

Trial Locations

Locations (6)

Long Beach VA Medical Center; 🇺🇸 Long Beach, California, United States

University of California Irvine Medical Center; 🇺🇸 Orange, California, United States

Jamaica Hospital; 🇺🇸 Jamaica, New York, United States

Lenox Hill Hospital; 🇺🇸 New York, New York, United States

Oklahoma VA Medical Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Baptist Hospital of Miami; 🇺🇸 Miami, Florida, United States