Clinical trial NCT01605292: Radial Artery Access With Ultrasound Trial
Official title: Radial Artery Access With Ultrasound Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Transradial catheterization
Ultrasound
Radial artery
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Lenox Hill Hospital
name: Jamaica Hospital Medical Center
name: Oklahoma City VA Medical Center
First posted: 2012-05-24
Enrollment: 698
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Attempts
timeFrame: Immediately during procedure. (up to 30 minutes)
Secondary outcomes:
measure: Time to Sheath Insertion (Seconds)
timeFrame: Immediately during procedure (within 30 minutes)
measure: First-pass Success Rate
timeFrame: Immediate
Other outcomes:
measure: Radial Artery Spasm
timeFrame: Immediately during procedure (within 30 min)
measure: Difficult Access Procedures >= 5 Attempts
timeFrame: Immediately during procedure (within 30 min)
measure: Difficult Access >= 5 Minutes
timeFrame: Immediate (within 30 minutes)
measure: Bleeding Complication
timeFrame: After procedure (within 24 hours)
measure: Pain Score
timeFrame: 2-8 hours after procedure
Locations:
city: Long Beach
country: United States
facility: Long Beach VA Medical Center
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Jamaica
country: United States
facility: Jamaica Hospital
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Oklahoma City
country: United States
facility: Oklahoma VA Medical Center
state: Oklahoma
Study officials:
affiliation: University of California, Irvine and Long Beach VA Medical Center
name: Arnold H Seto, MD, MPA
role: PRINCIPAL_INVESTIGATOR
affiliation: Lenox Hill Hospital
name: Zoran Lasic, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.