Time to Insertion of Radial Artery Cannulationart-lineNCT02118441
Ultrasound-guided Versus Direct Palpation Radial Artery Catheter Insertion Among Cardiac Anesthesiologists
A study testing Ultrasound-guided Radial Artery Catheter Insertion and Direct Palpation-guided Radial Artery Catheter insertion in people with Time to Insertion of Radial Artery Cannulation, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Time to Insertion of Radial Artery Cannulation
- What is being tested?
- Ultrasound-guided Radial Artery Catheter Insertion and Direct Palpation-guided Radial Artery Catheter insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2013to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing cardiac surgery
- Age 19 or older
- Provided written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Ultrasound-Guided Versus Direct Palpation For Radial Artery Catheterization Among Cardiac Anesthesiologists
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.
- Being tested
- Ultrasound-guided Radial Artery Catheter Insertion, Direct Palpation-guided Radial Artery Catheter insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Radial Artery Catheter InsertionDevice
Direct Palpation-guided Radial Artery Catheter insertionDevice
| Study group | Role | What they receive |
|---|---|---|
| direct palpation | Active comparator | Radial artery catheter insertion will be conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist. Receives: Device: Direct Palpation-guided Radial Artery Catheter insertion |
| Ultrasound | Active comparator | 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. Receives: Device: Ultrasound-guided Radial Artery Catheter Insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 5 minutes
Secondary outcomes (3)
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).
Measured: up to 5 minutes
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).
Measured: up to 5 minutes
Complication Rate (Hematoma)
A hematoma was defined a collection of blood or formation of a bruise surrounding the site of radial artery catheterization
Measured: up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startAug 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Time to Insertion of Radial Artery CannulationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Head, MD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118441
- Sponsor's protocol ID
- H13-00494
- Acronym
- art-line
- Status last verified
- Apr 2015
- First submitted
- 15 Apr 2014
- Last updated
- 7 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 34637140Peters 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
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Ultrasound-Guided Versus Direct Palpation For Radial Artery Catheterization Among Cardiac Anesthesiologists
- ClinicalTrials.gov ID
- NCT02118441
- Acronym / sponsor ID
- art-line / H13-00494
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Posted 7 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| direct palpation | Active comparator | Device: Direct Palpation-guided Radial Artery Catheter insertionRadial artery catheter insertion will be conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist. |
| Ultrasound | Active comparator | Device: Ultrasound-guided Radial Artery Catheter InsertionRadial 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing cardiac surgery
- Age 19 or older
- Provided written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided Radial Artery Catheter Insertion | Device | Ultrasound |
| Direct Palpation-guided Radial Artery Catheter insertion | Device | direct palpation |
Primary outcome
Time to Successful Radial Arterial Catheterization
Time frame: 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.
3 secondary outcomes
Number of Attempts
Time frame: up to 5 minutes
Number of Re-directions
Time frame: up to 5 minutes
Complication Rate (Hematoma)
Time frame: up to 5 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34637140Flumignan 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.
- Derived from this study: PubMed 26159436Peters 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Head, MD principal investigator
Providence Health & Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided Radial Artery Catheter Insertion and Direct Palpation-guided Radial Artery Catheter insertion in people with Time to Insertion of Radial Artery Cannulation, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Successful Radial Arterial Catheterization (time frame: up to 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02118441, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2015.