Radial Artery Access With Ultrasound Trial

Coronary Artery Disease Clinical Trial

— RAUST  

Official title:

Radial Artery Access With Ultrasound Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01605292
• Other study ID #: 2011-8432
• Status: Completed
• Phase: N/A
• First received: January 26, 2012
• Last updated: February 25, 2015
• Start date: December 2011
• Est. completion date: March 2013

Study information

• Verified date: February 2015
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 698
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Ultrasound guidance
Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.
• Palpation
Manual palpation for localizing radial artery for inserting needle.

Locations

Country	Name	City	State
United States	Jamaica Hospital	Jamaica	New York
United States	Long Beach VA Medical Center	Long Beach	California
United States	Baptist Hospital of Miami	Miami	Florida
United States	Lenox Hill Hospital	New York	New York
United States	Oklahoma VA Medical Center	Oklahoma City	Oklahoma
United States	University of California Irvine Medical Center	Orange	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Irvine	Jamaica Hospital Medical Center, Lenox Hill Hospital, Oklahoma City VA Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Radial Artery Spasm	Spasm defined and identified by the operator as any significant resistance or patient pain with catheter manipulation	Immediately during procedure (within 30 min)	No
Other	Difficult Access Procedures >= 5 Attempts	Difficult procedures were defined as either requiring >= 5 attempts	Immediately during procedure (within 30 min)	No
Other	Difficult Access >= 5 Minutes	Access that requires >= 5 minutes from first attempt to sheath insertion	Immediate (within 30 minutes)	No
Other	Bleeding Complication	Any hematoma >2 cm or bleeding requiring intervention	After procedure (within 24 hours)	No
Other	Pain Score	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.	2-8 hours after procedure	No
Primary	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.	Immediately during procedure. (up to 30 minutes)	No
Secondary	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.	Immediately during procedure (within 30 minutes)	No
Secondary	First-pass Success Rate	Proportion of procedures achieving access on the first attempt	Immediate	No