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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

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.

Condition or disease Intervention/treatment Phase
Time to Insertion of Radial Artery Cannulation Device: Ultrasound-guided Radial Artery Catheter Insertion Device: Direct Palpation-guided Radial Artery Catheter insertion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Comparison of Ultrasound-Guided Versus Direct Palpation For Radial Artery Catheterization Among Cardiac Anesthesiologists
Study Start Date : August 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: direct palpation
Radial artery catheter insertion will be conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.
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.

Device: Ultrasound-guided Radial Artery Catheter Insertion



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02118441


Locations
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Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Stephen Head, MD Providence Health & Services

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02118441     History of Changes
Other Study ID Numbers: H13-00494
First Posted: April 21, 2014    Key Record Dates
Results First Posted: May 7, 2015
Last Update Posted: May 7, 2015
Last Verified: April 2015