CClinicalTrials.gg
CompletedNCT02118441art-lineUpdated May 7, 2015Results posted

Ultrasound-guided Versus Direct Palpation Radial Artery Catheter Insertion Among Cardiac Anesthesiologists

An interventional study of Ultrasound-guided Radial Artery Catheter Insertion and Direct Palpation-guided Radial Artery Catheter insertion in Time to Insertion of Radial Artery Cannulation, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-07.

Sponsored by University of British Columbia · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
129
Allocation
Randomized
Ages
19 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Time to Insertion of Radial Artery Cannulation
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In context

Lead sponsor

University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients undergoing cardiac surgery
  • Age 19 or older
  • Provided written informed consent

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
129 participants (actual)

Study arms

  • Active comparator
    direct palpation

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

    Device: Direct Palpation-guided Radial Artery Catheter insertion

  • 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.

    Device: Ultrasound-guided Radial Artery Catheter Insertion

Interventions

  • DeviceUltrasound-guided Radial Artery Catheter Insertion
  • DeviceDirect Palpation-guided Radial Artery Catheter insertion
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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

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Results

Posted May 7, 2015

Participant flow

Participant flow — Overall Study
MilestoneDirect PalpationUltrasound
Started6564
Completed6263
Not completed31

Outcome measures

PrimaryTime 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
Reported as:
Median · seconds
Time to Successful Radial Arterial Catheterization
secondsDirect PalpationUltrasound
Time to Successful Radial Arterial Catheterization104 (76 to 212)104 (68 to 270)
SecondaryNumber 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
Reported as:
Median · number of attempts
Number of Attempts
number of attemptsDirect PalpationUltrasound
Number of Attempts1 (1 to 2)1 (1 to 2)
SecondaryNumber 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
Reported as:
Median · number of re-directs
Number of Re-directions
number of re-directsDirect PalpationUltrasound
Number of Re-directions2 (0 to 6)3 (1 to 5)
SecondaryComplication 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
Reported as:
Number · percentage of participants
Complication Rate (Hematoma)
percentage of participantsDirect PalpationUltrasound
Complication Rate (Hematoma)22.611.1

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Direct Palpation—0/62 (0%)14/62 (22.6%)
Ultrasound—0/63 (0%)7/63 (11.1%)
Most frequent other events
Most frequent other events
EventDirect PalpationUltrasound
hematomaVascular disorders14/627/63

Baseline characteristics

Age, Continuous
Age, Continuous(years)Direct PalpationUltrasoundTotal
Mean67 ± 1467 ± 1467 ± 14
Sex: Female, Male
Sex: Female, Male(Participants)Direct PalpationUltrasoundTotal
Female161127
Male465298
Region of Enrollment
Region of Enrollment(participants)Direct PalpationUltrasoundTotal
Canada6263125
Body Mass Index
Body Mass Index(kg/m^2)Direct PalpationUltrasoundTotal
Mean27 ± 526 ± 426.5 ± 4.5
ASA physical status IV
ASA physical status IV(participants)Direct PalpationUltrasoundTotal
Number6159120
Peripheral vascular disease
Peripheral vascular disease(participants)Direct PalpationUltrasoundTotal
Number336
Systolic Blood Pressure
Systolic Blood Pressure(mm Hg)Direct PalpationUltrasoundTotal
Mean140 ± 18140 ± 21140 ± 19.5
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Study locations

1 site
  • St. Paul's Hospital
    Vancouver, British Columbia V6Z 1Y6, Canada
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References and documents

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. PubMed 34637140 ↗
  • 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. PubMed 26159436 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02118441
Lead sponsor
University of British Columbia
Responsible party
Sponsor
First posted
Apr 21, 2014
Start date
Aug 2013
Primary completion
May 2014
Completion
May 2014
Results posted
May 7, 2015
Last update
May 7, 2015

Study contacts

Stephen Head, MD
principal investigator · Providence Health & Services

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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