Radial Artery Access With Ultrasound Trial
This study is currently recruiting participants.
Verified May 2012 by University of California, Irvine
Sponsor:
University of California, Irvine
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: May 22, 2012
Last verified: May 2012
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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.
| Estimated Enrollment: | 400 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605292
Contacts
| Contact: Arnold H Seto, MD, MPA | 7144566699 | aseto@uci.edu |
Locations
| United States, California | |
| Long Beach VA Medical Center | Recruiting |
| Long Beach, California, United States, 90822 | |
| Contact: Arnold H Seto, MD, MPA 714-456-6699 aseto@uci.edu | |
| University of California Irvine Medical Center | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Arnold H Seto, MD, MPA 714-456-6699 aseto@uci.edu | |
| United States, New York | |
| Jamaica Hospital | Recruiting |
| Jamaica, New York, United States, 11418 | |
| Contact: Zoran Lasic, MD 212-434-2606 | |
| Principal Investigator: Zoran Lasic, MD | |
| Lenox Hill Hospital | Active, not recruiting |
| New York, New York, United States, 10075 | |
| United States, Oklahoma | |
| Oklahoma VA Medical Center | Active, not recruiting |
| 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
No publications provided
| 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 |
| Last Updated: | May 22, 2012 |
| 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 Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013