Radial Artery Access With Ultrasound Trial
RAUST
1 other identifier
interventional
698
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Dec 2011
Shorter than P25 for not_applicable coronary-artery-disease
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 26, 2012
CompletedFirst Posted
Study publicly available on registry
May 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
February 26, 2015
CompletedFebruary 26, 2015
February 1, 2015
1.2 years
January 26, 2012
December 29, 2014
February 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Time to Sheath Insertion (Seconds)
Immediately during procedure (within 30 minutes)
First-pass Success Rate
Immediate
Other Outcomes (5)
Radial Artery Spasm
Immediately during procedure (within 30 min)
Difficult Access Procedures >= 5 Attempts
Immediately during procedure (within 30 min)
Difficult Access >= 5 Minutes
Immediate (within 30 minutes)
- +2 more other outcomes
Study Arms (2)
Palpation
ACTIVE COMPARATORManual palpation of radial pulse, as sole guide to needle cannulation.
Ultrasound
EXPERIMENTALReal-time ultrasound guidance to facilitate needle cannulation of artery.
Interventions
Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Inability to provide informed consent
- Femoral access
- Emergency procedure (Shock, STEMI)
- End-stage renal disease on hemodialysis
- Previous ipsilateral puncture within 1 week
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Irvinelead
- Lenox Hill Hospitalcollaborator
- Jamaica Hospital Medical Centercollaborator
- Oklahoma City VA Medical Centercollaborator
Study Sites (6)
Long Beach VA Medical Center
Long Beach, California, 90822, United States
University of California Irvine Medical Center
Orange, California, 92868, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
Jamaica Hospital
Jamaica, New York, 11418, United States
Lenox Hill Hospital
New York, New York, 10075, United States
Oklahoma VA Medical Center
Oklahoma City, Oklahoma, 73104, United States
Related Publications (2)
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.
PMID: 25596790RESULTFlumignan 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.
PMID: 34637140DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Blinding was not possible in this study. We cannot exclude a bias in the performance, measurement, or recording of the procedure or clinical data. Time to prepare the US probe was not included in the time to access.
Results Point of Contact
- Title
- Arnold Seto, MD, MPA
- Organization
- Long Beach VA Medical Center
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Clinical Professor
Study Record Dates
First Submitted
January 26, 2012
First Posted
May 24, 2012
Study Start
December 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
February 26, 2015
Results First Posted
February 26, 2015
Record last verified: 2015-02