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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Palpation; Procedure: Ultrasound guidance

• Study Type: Interventional
• Enrollment (Actual): 698
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90822
      • Long Beach VA Medical Center
    • Orange, California, United States, 92868
      • University of California Irvine Medical Center
  • Florida
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami
  • New York
    • Jamaica, New York, United States, 11418
      • Jamaica Hospital
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Palpation; Manual palpation of radial pulse, as sole guide to needle cannulation.	Procedure: Palpation; Manual palpation for localizing radial artery for inserting needle.
Experimental: Ultrasound; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Attempts	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.	Immediately during procedure. (up to 30 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Sheath Insertion (Seconds)	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.	Immediately during procedure (within 30 minutes)
First-pass Success Rate	Proportion of procedures achieving access on the first attempt	Immediate

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radial Artery Spasm	Spasm defined and identified by the operator as any significant resistance or patient pain with catheter manipulation	Immediately during procedure (within 30 min)
Difficult Access Procedures >= 5 Attempts	Difficult procedures were defined as either requiring >= 5 attempts	Immediately during procedure (within 30 min)
Difficult Access >= 5 Minutes	Access that requires >= 5 minutes from first attempt to sheath insertion	Immediate (within 30 minutes)
Bleeding Complication	Any hematoma >2 cm or bleeding requiring intervention	After procedure (within 24 hours)
Pain Score	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.	2-8 hours after procedure

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: Lenox Hill Hospital; Jamaica Hospital Medical Center; Oklahoma City VA Medical Center
• Investigators: 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

Publications and helpful links

General Publications

• Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
• Seto AH, Roberts JS, Abu-Fadel MS, Czak SJ, Latif F, Jain SP, Raza JA, Mangla A, Panagopoulos G, Patel PM, Kern MJ, Lasic Z. Real-time ultrasound guidance facilitates transradial access: RAUST (Radial Artery access with Ultrasound Trial). JACC Cardiovasc Interv. 2015 Feb;8(2):283-291. doi: 10.1016/j.jcin.2014.05.036. Epub 2015 Jan 14.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: January 26, 2012
• First Submitted That Met QC Criteria: May 22, 2012
• First Posted (Estimate): May 24, 2012

Study Record Updates

• Last Update Posted (Estimate): February 26, 2015
• Last Update Submitted That Met QC Criteria: February 25, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Ultrasound; Transradial catheterization; Radial artery
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 2011-8432