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Radial Artery Access With Ultrasound Trial (RAUST)

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ClinicalTrials.gov Identifier: NCT01605292
Recruitment Status : Completed
First Posted : May 24, 2012
Results First Posted : February 26, 2015
Last Update Posted : February 26, 2015
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Ultrasound guidance Procedure: Palpation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 698 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. First-pass Success Rate [ Time Frame: Immediate ]
    Proportion of procedures achieving access on the first attempt


Other Outcome Measures:
  1. 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

  2. Difficult Access Procedures >= 5 Attempts [ Time Frame: Immediately during procedure (within 30 min) ]
    Difficult procedures were defined as either requiring >= 5 attempts

  3. Difficult Access >= 5 Minutes [ Time Frame: Immediate (within 30 minutes) ]
    Access that requires >= 5 minutes from first attempt to sheath insertion

  4. Bleeding Complication [ Time Frame: After procedure (within 24 hours) ]
    Any hematoma >2 cm or bleeding requiring intervention

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Locations
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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
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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
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Arnold Seto, Assistant Clinical Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01605292    
Other Study ID Numbers: 2011-8432
First Posted: May 24, 2012    Key Record Dates
Results First Posted: February 26, 2015
Last Update Posted: February 26, 2015
Last Verified: February 2015
Keywords provided by Arnold Seto, University of California, Irvine:
Transradial catheterization
Ultrasound
Radial artery
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases