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Ultrasound-guided Versus Direct Palpation Radial Artery Catheter Insertion Among Cardiac Anesthesiologists (art-line)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Time to Insertion of Radial Artery Cannulation
Interventions Device: Ultrasound-guided Radial Artery Catheter Insertion
Device: Direct Palpation-guided Radial Artery Catheter insertion
Enrollment 129
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Direct Palpation Ultrasound
Hide Arm/Group Description

Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.

Direct Palpation-guided Radial Artery Catheter insertion

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

Period Title: Overall Study
Started 65 64
Completed 62 63
Not Completed 3 1
Arm/Group Title Direct Palpation Ultrasound Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 62 63 125
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 63 participants 125 participants
67  (14) 67  (14) 67  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 63 participants 125 participants
Female
16
  25.8%
11
  17.5%
27
  21.6%
Male
46
  74.2%
52
  82.5%
98
  78.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 62 participants 63 participants 125 participants
62 63 125
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 62 participants 63 participants 125 participants
27  (5) 26  (4) 26.5  (4.5)
ASA physical status IV   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 62 participants 63 participants 125 participants
61 59 120
[1]
Measure Description: American Society of Anesthesiologists (ASA) status is a system for assessing fitness for surgery. Class IV refers to patients who have severe systemic disease that is a constant threat to life. Status I refers to a healthy patient. Status II refers to patients with mild systemic disease. Status III refers to patients who have severe systemic disease. Thus ASA class IV patients are associated with higher morbidity and mortality compared to ASA 1 patients.
Peripheral vascular disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 62 participants 63 participants 125 participants
3 3 6
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 62 participants 63 participants 125 participants
140  (18) 140  (21) 140  (19.5)
1.Primary Outcome
Title Time to Successful Radial Arterial Catheterization
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Direct Palpation Ultrasound
Hide Arm/Group Description:

Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.

Direct Palpation-guided Radial Artery Catheter insertion

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 Number of Participants Analyzed 62 63
Median (Inter-Quartile Range)
Unit of Measure: seconds
104
(76 to 212)
104
(68 to 270)
2.Secondary Outcome
Title Number of Attempts
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Direct Palpation Ultrasound
Hide Arm/Group Description:

Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.

Direct Palpation-guided Radial Artery Catheter insertion

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 Number of Participants Analyzed 62 63
Median (Inter-Quartile Range)
Unit of Measure: number of attempts
1
(1 to 2)
1
(1 to 2)
3.Secondary Outcome
Title Number of Re-directions
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Direct Palpation Ultrasound
Hide Arm/Group Description:

Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.

Direct Palpation-guided Radial Artery Catheter insertion

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 Number of Participants Analyzed 62 63
Median (Inter-Quartile Range)
Unit of Measure: number of re-directs
2
(0 to 6)
3
(1 to 5)
4.Secondary Outcome
Title Complication Rate (Hematoma)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Direct Palpation Ultrasound
Hide Arm/Group Description:

Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.

Direct Palpation-guided Radial Artery Catheter insertion

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

Overall Number of Participants Analyzed 62 63
Measure Type: Number
Unit of Measure: percentage of participants
22.6 11.1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Direct Palpation Ultrasound
Hide Arm/Group Description

Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.

Direct Palpation-guided Radial Artery Catheter insertion

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

All-Cause Mortality
Direct Palpation Ultrasound
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Direct Palpation Ultrasound
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/62 (0.00%)      0/63 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Direct Palpation Ultrasound
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/62 (22.58%)      7/63 (11.11%)    
Vascular disorders     
hematoma   14/62 (22.58%)  14 7/63 (11.11%)  7
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: S. K. W. Schwarz, MD, PhD
Organization: Department of Anesthesia, St. Paul's Hospital
Phone: 604-806-8337
EMail: stephan.schwarz@ubc.ca
Layout table for additonal information
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02118441    
Other Study ID Numbers: H13-00494
First Submitted: April 15, 2014
First Posted: April 21, 2014
Results First Submitted: March 3, 2015
Results First Posted: May 7, 2015
Last Update Posted: May 7, 2015