Time to Insertion of Radial Artery Cannulation
Conditions
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.
Interventions
DEVICEUltrasound-guided Radial Artery Catheter Insertion
DEVICEDirect Palpation-guided Radial Artery Catheter insertion
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Successful Radial Arterial Catheterization | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Attempts | 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 | 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) | up to 5 minutes | A hematoma was defined a collection of blood or formation of a bruise surrounding the site of radial artery catheterization |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Direct Palpation Radial artery catheter insertion will be conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.
Direct Palpation-guided Radial Artery Catheter insertion | 62 |
| 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.
Ultrasound-guided Radial Artery Catheter Insertion | 63 |
| Total | 125 |
Baseline characteristics
| Characteristic | Total | Direct Palpation | Ultrasound |
|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 14 | 67 years STANDARD_DEVIATION 14 | 67 years STANDARD_DEVIATION 14 |
| ASA physical status IV | 120 participants | 61 participants | 59 participants |
| Body Mass Index | 26.5 kg/m^2 STANDARD_DEVIATION 4.5 | 27 kg/m^2 STANDARD_DEVIATION 5 | 26 kg/m^2 STANDARD_DEVIATION 4 |
| Peripheral vascular disease | 6 participants | 3 participants | 3 participants |
| Region of Enrollment Canada | 125 participants | 62 participants | 63 participants |
| Sex: Female, Male Female | 27 Participants | 16 Participants | 11 Participants |
| Sex: Female, Male Male | 98 Participants | 46 Participants | 52 Participants |
| Systolic Blood Pressure | 140 mm Hg STANDARD_DEVIATION 19.5 | 140 mm Hg STANDARD_DEVIATION 18 | 140 mm Hg STANDARD_DEVIATION 21 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 62 | 7 / 63 |
| serious Total, serious adverse events | 0 / 62 | 0 / 63 |
Outcome results
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.
Time frame: up to 5 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Direct Palpation | Time to Successful Radial Arterial Catheterization | 104 seconds |
| Ultrasound | Time to Successful Radial Arterial Catheterization | 104 seconds |
Secondary
Complication Rate (Hematoma)
A hematoma was defined a collection of blood or formation of a bruise surrounding the site of radial artery catheterization
Time frame: up to 5 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Direct Palpation | Complication Rate (Hematoma) | 22.6 percentage of participants |
| Ultrasound | Complication Rate (Hematoma) | 11.1 percentage of participants |
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).
Time frame: up to 5 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Direct Palpation | Number of Attempts | 1 number of attempts |
| Ultrasound | Number of Attempts | 1 number of attempts |
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).
Time frame: up to 5 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Direct Palpation | Number of Re-directions | 2 number of re-directs |
| Ultrasound | Number of Re-directions | 3 number of re-directs |