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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02118441
Other study ID # H13-00494
Secondary ID
Status Completed
Phase N/A
First received April 15, 2014
Last updated April 21, 2015
Start date August 2013
Est. completion date May 2014

Study information

Verified date April 2015
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 129
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms

  • Time to Insertion of Radial Artery Cannulation

Intervention

Device:
Ultrasound-guided Radial Artery Catheter Insertion

Direct Palpation-guided Radial Artery Catheter insertion


Locations

Country Name City State
Canada St. Paul's Hospital Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to Successful Radial Arterial Catheterization 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 No
Secondary Number of Attempts 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 No
Secondary Number of Re-directions 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 No
Secondary Complication Rate (Hematoma) A hematoma was defined a collection of blood or formation of a bruise surrounding the site of radial artery catheterization up to 5 minutes No