Radial Artery Access With Ultrasound Trial (RAUST)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Radial Artery Access With Ultrasound Trial|
- Number of Attempts [ Time Frame: Immediately during procedure. (up to 30 minutes) ] [ Designated as safety issue: No ]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.
- Time to Sheath Insertion (Seconds) [ Time Frame: Immediately during procedure (within 30 minutes) ] [ Designated as safety issue: No ]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 [ Time Frame: Immediate ] [ Designated as safety issue: No ]Proportion of procedures achieving access on the first attempt
- Radial Artery Spasm [ Time Frame: Immediately during procedure (within 30 min) ] [ Designated as safety issue: No ]Spasm defined and identified by the operator as any significant resistance or patient pain with catheter manipulation
- Difficult Access Procedures >= 5 Attempts [ Time Frame: Immediately during procedure (within 30 min) ] [ Designated as safety issue: No ]Difficult procedures were defined as either requiring >= 5 attempts
- Difficult Access >= 5 Minutes [ Time Frame: Immediate (within 30 minutes) ] [ Designated as safety issue: No ]Access that requires >= 5 minutes from first attempt to sheath insertion
- Bleeding Complication [ Time Frame: After procedure (within 24 hours) ] [ Designated as safety issue: No ]Any hematoma >2 cm or bleeding requiring intervention
- Pain Score [ Time Frame: 2-8 hours after procedure ] [ Designated as safety issue: No ]Patient-reported wrist pain using a visual-analogue scale (0-10) 2-8 hours after the procedure, where 0 is no pain and 10 is severe pain.
|Study Start Date:||December 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Palpation
Manual palpation of radial pulse, as sole guide to needle cannulation.
Manual palpation for localizing radial artery for inserting needle.
Real-time ultrasound guidance to facilitate needle cannulation of artery.
Procedure: Ultrasound guidance
Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605292
|United States, California|
|Long Beach VA Medical Center|
|Long Beach, California, United States, 90822|
|University of California Irvine Medical Center|
|Orange, California, United States, 92868|
|United States, Florida|
|Baptist Hospital of Miami|
|Miami, Florida, United States, 33176|
|United States, New York|
|Jamaica, New York, United States, 11418|
|Lenox Hill Hospital|
|New York, New York, United States, 10075|
|United States, Oklahoma|
|Oklahoma VA Medical Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||Arnold H Seto, MD, MPA||University of California, Irvine and Long Beach VA Medical Center|
|Principal Investigator:||Zoran Lasic, MD||Lenox Hill Hospital|