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Completed

NCT Number: NCT01605292

Radial Artery Access With Ultrasound Trial

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Long Beach VA Medical Center, Long Beach, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound guidance

Procedure

Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.

Palpation

Procedure

Manual palpation for localizing radial artery for inserting needle.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • Jamaica Hospital Medical Center
  • Lenox Hill Hospital
  • Oklahoma City VA Medical Center

Registry information

Acronym: RAUST

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 24, 2012
Registry last updated
Feb 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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