Radial Artery Access With Ultrasound Trial (RAUST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01605292|
Recruitment Status : Completed
First Posted : May 24, 2012
Results First Posted : February 26, 2015
Last Update Posted : February 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Procedure: Ultrasound guidance Procedure: Palpation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||698 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Radial Artery Access With Ultrasound Trial|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
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.
- Number of Attempts [ Time Frame: 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.
- Time to Sheath Insertion (Seconds) [ Time Frame: 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 [ Time Frame: Immediate ]Proportion of procedures achieving access on the first attempt
- Radial Artery Spasm [ Time Frame: Immediately during procedure (within 30 min) ]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) ]Difficult procedures were defined as either requiring >= 5 attempts
- Difficult Access >= 5 Minutes [ Time Frame: Immediate (within 30 minutes) ]Access that requires >= 5 minutes from first attempt to sheath insertion
- Bleeding Complication [ Time Frame: After procedure (within 24 hours) ]Any hematoma >2 cm or bleeding requiring intervention
- Pain Score [ Time Frame: 2-8 hours after procedure ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|