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Ultrasound-guided Versus Direct Palpation Radial Artery Catheter Insertion Among Cardiac Anesthesiologists (art-line)

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ClinicalTrials.gov Identifier: NCT02118441
Recruitment Status : Completed
First Posted : April 21, 2014
Results First Posted : May 7, 2015
Last Update Posted : May 7, 2015
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

Tracking Information
First Submitted Date  ICMJE April 15, 2014
First Posted Date  ICMJE April 21, 2014
Results First Submitted Date  ICMJE March 3, 2015
Results First Posted Date  ICMJE May 7, 2015
Last Update Posted Date May 7, 2015
Study Start Date  ICMJE August 2013
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2015)
Time to Successful Radial Arterial Catheterization [ Time Frame: up to 5 minutes ]
The time to successful radial arterial catheterization was defined as time zero to time of placement. Time zero for the DP group began when the anesthesiologist's fingers were placed on the patient with the purpose of palpating the artery. Time zero for the US group began when the US transducer was first placed on the patient's skin for the purpose of identifying the radial artery. Time to placement was defined as the interval from time zero until the time at which an arterial tracing was viewed on the monitor.
Original Primary Outcome Measures  ICMJE
 (submitted: April 16, 2014)
Time to Successful Radial Arterial Catheterization [ Time Frame: one year ]
Change History Complete list of historical versions of study NCT02118441 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2015)
  • Number of Attempts [ Time Frame: up to 5 minutes ]
    An attempt was defined as a new purposeful penetration of the skin with the needle (i.e., following complete withdrawal of the needle from the skin).
  • Number of Re-directions [ Time Frame: up to 5 minutes ]
    A re-direct was defined as the needle being purposefully withdrawn at least 5 mm and re-directed (but not removed from the skin entirely).
  • Complication Rate (Hematoma) [ Time Frame: up to 5 minutes ]
    A hematoma was defined a collection of blood or formation of a bruise surrounding the site of radial artery catheterization
Original Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2014)
  • Number of Attempts [ Time Frame: one year ]
  • Number of Re-directions [ Time Frame: one year ]
  • Complication Rate (Hematoma) [ Time Frame: one year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultrasound-guided Versus Direct Palpation Radial Artery Catheter Insertion Among Cardiac Anesthesiologists
Official Title  ICMJE A Comparison of Ultrasound-Guided Versus Direct Palpation For Radial Artery Catheterization Among Cardiac Anesthesiologists
Brief Summary When a patient undergoes heart surgery, their Anesthesiologist will insert a tiny plastic tube, called a catheter, in the artery of the patient's wrist. This is called a radial artery catheter. A radial artery catheter allows accurate measurement of the patient's blood pressure during surgery. There are two common techniques for placing the radial artery catheter. The first is a "blind" technique whereby the Anesthesiologist feels for the pulse in the patient's wrist and places the catheter using the location of the pulse as a guide. The second technique, less commonly used, is one whereby the Anesthesiologist uses an ultrasound machine (painless to the patient) to "see" the artery, and thereby uses the ultrasound to guide the catheter placement. Our study will test the hypothesis that ultrasound-guided radial artery catheterization will have faster insertion times, with fewer complications compared with palpation-guided insertion.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Time to Insertion of Radial Artery Cannulation
Intervention  ICMJE
  • Device: Ultrasound-guided Radial Artery Catheter Insertion
  • Device: Direct Palpation-guided Radial Artery Catheter insertion
Study Arms  ICMJE
  • Active Comparator: direct palpation
    Radial artery catheter insertion will be conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.
    Intervention: Device: Direct Palpation-guided Radial Artery Catheter insertion
  • Active Comparator: Ultrasound

    Radial artery catheter insertion will be conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer will be used.

    At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) will be used. Colour flow doppler may also be used to identify the artery if necessary.

    Intervention: Device: Ultrasound-guided Radial Artery Catheter Insertion
Publications * Peters C, Schwarz SK, Yarnold CH, Kojic K, Kojic S, Head SJ. Ultrasound guidance versus direct palpation for radial artery catheterization by expert operators: a randomized trial among Canadian cardiac anesthesiologists. Can J Anaesth. 2015 Nov;62(11):1161-8. doi: 10.1007/s12630-015-0426-8. Epub 2015 Jul 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2014)
129
Original Estimated Enrollment  ICMJE
 (submitted: April 16, 2014)
120
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing cardiac surgery
  • Age 19 or older
  • Provided written informed consent

Exclusion Criteria:

  • Suspected inability to comply with study procedures, including language difficulties or medical history and/or concomitant disease, as judged by the investigator
  • Previous surgery at the site of proposed radial artery catheterization
  • Any vascular condition that may preclude eligibility for radial artery line insertion as judged by the investigator
  • Patients with ventricular assist devices
  • Previous inclusion in this study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02118441
Other Study ID Numbers  ICMJE H13-00494
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephen Head, MD Providence Health & Services
PRS Account University of British Columbia
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP