- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02118441
Ultrasound-guided Versus Direct Palpation Radial Artery Catheter Insertion Among Cardiac Anesthesiologists (art-line)
A Comparison of Ultrasound-Guided Versus Direct Palpation For Radial Artery Catheterization Among Cardiac Anesthesiologists
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
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Vancouver, British Columbia, Canada, V6Z 1Y6
- St. Paul's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
up to 5 minutes
|
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).
|
up to 5 minutes
|
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
|
up to 5 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephen Head, MD, Providence Health & Services
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H13-00494
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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