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Radial Artery Access With Ultrasound Trial (RAUST)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound guidance
Palpation
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Transradial catheterization, Ultrasound, Radial artery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Long Beach VA Medical Center
  • University of California Irvine Medical Center
  • Baptist Hospital of Miami
  • Jamaica Hospital
  • Lenox Hill Hospital
  • Oklahoma VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Palpation

Ultrasound

Arm Description

Manual palpation of radial pulse, as sole guide to needle cannulation.

Real-time ultrasound guidance to facilitate needle cannulation of artery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
First-pass Success Rate
Proportion of procedures achieving access on the first attempt

Full Information

First Posted
January 26, 2012
Last Updated
February 25, 2015
Sponsor
University of California, Irvine
Collaborators
Lenox Hill Hospital, Jamaica Hospital Medical Center, Oklahoma City VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01605292
Brief Title
Radial Artery Access With Ultrasound Trial
Acronym
RAUST
Official Title
Radial Artery Access With Ultrasound Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
Lenox Hill Hospital, Jamaica Hospital Medical Center, Oklahoma City VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Transradial catheterization, Ultrasound, Radial artery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
698 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Palpation
Arm Type
Active Comparator
Arm Description
Manual palpation of radial pulse, as sole guide to needle cannulation.
Arm Title
Ultrasound
Arm Type
Experimental
Arm Description
Real-time ultrasound guidance to facilitate needle cannulation of artery.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guidance
Intervention Description
Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.
Intervention Type
Procedure
Intervention Name(s)
Palpation
Intervention Description
Manual palpation for localizing radial artery for inserting needle.
Primary Outcome Measure Information:
Title
Number of Attempts
Description
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 Frame
Immediately during procedure. (up to 30 minutes)
Secondary Outcome Measure Information:
Title
Time to Sheath Insertion (Seconds)
Description
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.
Time Frame
Immediately during procedure (within 30 minutes)
Title
First-pass Success Rate
Description
Proportion of procedures achieving access on the first attempt
Time Frame
Immediate
Other Pre-specified Outcome Measures:
Title
Radial Artery Spasm
Description
Spasm defined and identified by the operator as any significant resistance or patient pain with catheter manipulation
Time Frame
Immediately during procedure (within 30 min)
Title
Difficult Access Procedures >= 5 Attempts
Description
Difficult procedures were defined as either requiring >= 5 attempts
Time Frame
Immediately during procedure (within 30 min)
Title
Difficult Access >= 5 Minutes
Description
Access that requires >= 5 minutes from first attempt to sheath insertion
Time Frame
Immediate (within 30 minutes)
Title
Bleeding Complication
Description
Any hematoma >2 cm or bleeding requiring intervention
Time Frame
After procedure (within 24 hours)
Title
Pain Score
Description
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.
Time Frame
2-8 hours after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnold H Seto, MD, MPA
Organizational Affiliation
University of California, Irvine and Long Beach VA Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zoran Lasic, MD
Organizational Affiliation
Lenox Hill Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Long Beach VA Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Jamaica Hospital
City
Jamaica
State/Province
New York
ZIP/Postal Code
11418
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Oklahoma VA Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25596790
Citation
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.
Results Reference
result
PubMed Identifier
34637140
Citation
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.
Results Reference
derived

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Radial Artery Access With Ultrasound Trial

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