Trial Outcomes & Findings for Ultrasound-guided Versus Direct Palpation Radial Artery Catheter Insertion Among Cardiac Anesthesiologists (NCT NCT02118441)
NCT ID: NCT02118441
Last Updated: 2015-05-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
129 participants
Primary outcome timeframe
up to 5 minutes
Results posted on
2015-05-07
Participant Flow
Participant milestones
| Measure |
Direct Palpation
Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.
Direct Palpation-guided Radial Artery Catheter insertion
|
Ultrasound
Radial artery catheter insertion was 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 was used.
At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may have also been used to identify the artery if necessary.
Ultrasound-guided Radial Artery Catheter Insertion
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
64
|
|
Overall Study
COMPLETED
|
62
|
63
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ultrasound-guided Versus Direct Palpation Radial Artery Catheter Insertion Among Cardiac Anesthesiologists
Baseline characteristics by cohort
| Measure |
Direct Palpation
n=62 Participants
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
|
Ultrasound
n=63 Participants
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
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 14 • n=5 Participants
|
67 years
STANDARD_DEVIATION 14 • n=7 Participants
|
67 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
62 participants
n=5 Participants
|
63 participants
n=7 Participants
|
125 participants
n=5 Participants
|
|
Body Mass Index
|
27 kg/m^2
STANDARD_DEVIATION 5 • n=5 Participants
|
26 kg/m^2
STANDARD_DEVIATION 4 • n=7 Participants
|
26.5 kg/m^2
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
ASA physical status IV
|
61 participants
n=5 Participants
|
59 participants
n=7 Participants
|
120 participants
n=5 Participants
|
|
Peripheral vascular disease
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Systolic Blood Pressure
|
140 mm Hg
STANDARD_DEVIATION 18 • n=5 Participants
|
140 mm Hg
STANDARD_DEVIATION 21 • n=7 Participants
|
140 mm Hg
STANDARD_DEVIATION 19.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: up to 5 minutesThe 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.
Outcome measures
| Measure |
Direct Palpation
n=62 Participants
Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.
Direct Palpation-guided Radial Artery Catheter insertion
|
Ultrasound
n=63 Participants
Radial artery catheter insertion was 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 was used.
At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may have also been used to identify the artery if necessary.
Ultrasound-guided Radial Artery Catheter Insertion
|
|---|---|---|
|
Time to Successful Radial Arterial Catheterization
|
104 seconds
Interval 76.0 to 212.0
|
104 seconds
Interval 68.0 to 270.0
|
SECONDARY outcome
Timeframe: up to 5 minutesAn 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).
Outcome measures
| Measure |
Direct Palpation
n=62 Participants
Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.
Direct Palpation-guided Radial Artery Catheter insertion
|
Ultrasound
n=63 Participants
Radial artery catheter insertion was 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 was used.
At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may have also been used to identify the artery if necessary.
Ultrasound-guided Radial Artery Catheter Insertion
|
|---|---|---|
|
Number of Attempts
|
1 number of attempts
Interval 1.0 to 2.0
|
1 number of attempts
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: up to 5 minutesA re-direct was defined as the needle being purposefully withdrawn at least 5 mm and re-directed (but not removed from the skin entirely).
Outcome measures
| Measure |
Direct Palpation
n=62 Participants
Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.
Direct Palpation-guided Radial Artery Catheter insertion
|
Ultrasound
n=63 Participants
Radial artery catheter insertion was 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 was used.
At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may have also been used to identify the artery if necessary.
Ultrasound-guided Radial Artery Catheter Insertion
|
|---|---|---|
|
Number of Re-directions
|
2 number of re-directs
Interval 0.0 to 6.0
|
3 number of re-directs
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: up to 5 minutesA hematoma was defined a collection of blood or formation of a bruise surrounding the site of radial artery catheterization
Outcome measures
| Measure |
Direct Palpation
n=62 Participants
Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.
Direct Palpation-guided Radial Artery Catheter insertion
|
Ultrasound
n=63 Participants
Radial artery catheter insertion was 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 was used.
At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may have also been used to identify the artery if necessary.
Ultrasound-guided Radial Artery Catheter Insertion
|
|---|---|---|
|
Complication Rate (Hematoma)
|
22.6 percentage of participants
|
11.1 percentage of participants
|
Adverse Events
Direct Palpation
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Ultrasound
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Direct Palpation
n=62 participants at risk
Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.
Direct Palpation-guided Radial Artery Catheter insertion
|
Ultrasound
n=63 participants at risk
Radial artery catheter insertion was 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 was used.
At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may also have been used to identify the artery if necessary.
Ultrasound-guided Radial Artery Catheter Insertion
|
|---|---|---|
|
Vascular disorders
hematoma
|
22.6%
14/62 • Number of events 14
|
11.1%
7/63 • Number of events 7
|
Additional Information
S. K. W. Schwarz, MD, PhD
Department of Anesthesia, St. Paul's Hospital
Phone: 604-806-8337
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place