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Radial Artery Access With Ultrasound Trial (RAUST)

This study has been completed.
Sponsor:
Collaborators:
Lenox Hill Hospital
Jamaica Hospital Medical Center
Oklahoma City VA Medical Center
Information provided by (Responsible Party):
Arnold Seto, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01605292
First received: January 26, 2012
Last updated: February 25, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Procedure: Ultrasound guidance
Procedure: Palpation

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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.


Enrollment: 698
Study Start Date: December 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605292

Locations
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 Hospital
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
Sponsors and Collaborators
University of California, Irvine
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
  More Information

Publications:
Responsible Party: Arnold Seto, Assistant Clinical Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01605292     History of Changes
Other Study ID Numbers: 2011-8432
Study First Received: January 26, 2012
Results First Received: December 29, 2014
Last Updated: February 25, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Transradial catheterization
Ultrasound
Radial artery

Additional relevant MeSH terms:
Coronary Artery Disease
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on March 03, 2015