Cardiac and Aortic SurgeryEPRACNCT04730479
Echography to Predict Radial Artery Catheterization Failure (EPRAC)
An observational study of Cardiac and Aortic Surgery, run by University Hospital, Montpellier at 1 site in France.
Trial summary
In patients undergoing cardiac or aortic surgery, the placement of a radial KTA is sometimes difficult, the purpose of this study is to do an ultrasound in order to evaluate the diagnostic values of the internal diameter of the radial artery to predict the failure to install the radial KTA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac and Aortic Surgery
- How many people
- 330 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2021to 11 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult who have an scheduled cardiac or aortic surgery at Montpellier University Hospital
Who may be able to join
- Aged from 18 years old
- Be operated for a scheduled cardiac or aortic surgery
- Be able to complete all the visits and follow the study procedures
- Subjects must be covered by public health insurance
Who cannot join
- Patients protected by law or Absence of signed informed consent
- Emergency Surgery Patient
- Patient already with an arterial catheter
- Patient with Radial Arterial Catheter Contraindication
- Radial arterial catheter placed by an anesthesiologist nurse student
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Prediction of Radial Arterial Catheterization Failure in Patients Undergoing Cardiac or Aortic Surgery: a Prospective Study
In patients undergoing cardiac or aortic surgery, the placement of a radial KTA is sometimes difficult, the purpose of this study is to do an ultrasound in order to evaluate the diagnostic values of the internal diameter of the radial artery to predict the failure to install the radial KTA.
Read the detailed description
The Arterial Catheter (KTA) enables continuous measurement of invasive blood pressure in patients with accurate and reliable hemodynamic monitoring. Radial Artery Catheterization is the currently recommended placement site.
In patients undergoing cardiac or aortic surgery, placement of a radial KTA is sometimes difficult, with a failure rate of around 15%. It is also a source of local complications and prolongation of the anesthetic duration.
There is no predictive diagnostic test for failed radial KTA placement in anesthesia.
Accurately predicting the failure of radial catheterization by echography will, in the future, make it possible to offer "at risk" patients an immediate catheterization in an other site as for example brachial site.
- Conditions
- Cardiac and Aortic Surgery
- Keywords
- ultrasonography, radial artery catheterization, probabilistic model, adult
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure to insert a radial artery catheter (KTA) by the nurse anesthesiologists
Failure to insert the radial KTA by the nurse anesthesiologist defined as follows: ≥ 3 punctures (by the nurse anesthetist) or need to change of doctor operator (nurse anesthesiologist to Anesthesiologist - Resuscitator) or change of puncture site (radial to radial contralateral or other site). All professionals involved are blinded to the echographic measures of the radial artery.
Measured: Day 1
Secondary outcomes (11)
Internal radial artery diameter
Measured on echographic exam. Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient). Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician.
Measured: Day 1
External radial artery diameter
Measured on echographic exam. Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient). Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician.
Measured: Day 1
Internal area of the radial artery
Measured on echographic exam. Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient). Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician.
Measured: Day 1
External area of the radial artery
Measured on echographic exam. Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient). Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician.
Measured: Day 1
Calcification of arterial wall (yes/no)
Measured on echographic exam. Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient). Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician.
Measured: Day 1
Thickness of arteria wall
Measured on echographic exam. Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient). Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician.
Measured: Day 1
Ratio between internal and external arteria diameter
Measured on echographic exam. Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient). Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician.
Measured: Day 1
Clinical characteristics at baseline
Age, sex, body mass index, ASA score, duration of preoperative fasting, cardiovascular risk factors, cardiovascular conditions, wrist circumference, pulse force of the radial, ulnar, and brachial arteries (no pulse / feeble pulse / normal pulse), mean arterial pressure at punction time, dose of vasopressants (ephedrine, neosynephrine, noradrenaline) at punction time
Measured: Day 1
Punction-related adverse events
Hematoma, dissection, thrombosis, ischemia, false aneuvrysm, infection, pain.
Measured: 6 months
Duration of arterial punction
delay between first pulse palpation and end of bandage on a functional catheter
Measured: Day 1
Duration of patient management
duration of anaesthesia, duration of presence in surgery room, length of hospital stay
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start15 Apr 2021
- Primary completion6 Apr 2022
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac and Aortic SurgeryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme PANIEGO, Principal investigator, University hospital of Montpellier, Montpellier, France, 34295
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730479
- Sponsor's protocol ID
- RECHMPL20_0091
- Acronym
- EPRAC
- Status last verified
- Oct 2022
- First submitted
- 25 Jan 2021
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Paniego J, Boge G, Mourad M, Duflos C, Van Rens M, Ruiz R, Lorne E, Sentenac P. Ultrasound to predict radial artery catheterization failure in patients undergoing major cardiovascular surgery (UPRAC). J Vasc Access. 2026 Jun 23:11297298261455502. doi: 10.1177/11297298261455502. Online ahead of print.
PubMed 42338037
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Prediction of Radial Arterial Catheterization Failure in Patients Undergoing Cardiac or Aortic Surgery: a Prospective Study
- ClinicalTrials.gov ID
- NCT04730479
- Acronym / sponsor ID
- EPRAC / RECHMPL20_0091
- Conditions
- Cardiac and Aortic Surgery
- Keywords
- ultrasonography, radial artery catheterization, probabilistic model, adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In patients undergoing cardiac or aortic surgery, the placement of a radial KTA is sometimes difficult, the purpose of this study is to do an ultrasound in order to evaluate the diagnostic values of the internal diameter of the radial artery to predict the failure to install the radial KTA.
Detailed description
The Arterial Catheter (KTA) enables continuous measurement of invasive blood pressure in patients with accurate and reliable hemodynamic monitoring. Radial Artery Catheterization is the currently recommended placement site.
In patients undergoing cardiac or aortic surgery, placement of a radial KTA is sometimes difficult, with a failure rate of around 15%. It is also a source of local complications and prolongation of the anesthetic duration.
There is no predictive diagnostic test for failed radial KTA placement in anesthesia.
Accurately predicting the failure of radial catheterization by echography will, in the future, make it possible to offer "at risk" patients an immediate catheterization in an other site as for example brachial site.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult who have an scheduled cardiac or aortic surgery at Montpellier University Hospital
Key inclusion criteria (4 listed)
- Aged from 18 years old
- Be operated for a scheduled cardiac or aortic surgery
- Be able to complete all the visits and follow the study procedures
- Subjects must be covered by public health insurance
Key exclusion criteria (5 listed)
- Patients protected by law or Absence of signed informed consent
- Emergency Surgery Patient
- Patient already with an arterial catheter
- Patient with Radial Arterial Catheter Contraindication
- Radial arterial catheter placed by an anesthesiologist nurse student
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Failure to insert a radial artery catheter (KTA) by the nurse anesthesiologists
Time frame: Day 1
Failure to insert the radial KTA by the nurse anesthesiologist defined as follows: ≥ 3 punctures (by the nurse anesthetist) or need to change of doctor operator (nurse anesthesiologist to Anesthesiologist - Resuscitator) or change of puncture site (radial to radial contralateral or other site). All professionals involved are blinded to the echographic measures of the radial artery.
11 secondary outcomes
Internal radial artery diameter
Time frame: Day 1
External radial artery diameter
Time frame: Day 1
Internal area of the radial artery
Time frame: Day 1
External area of the radial artery
Time frame: Day 1
Calcification of arterial wall (yes/no)
Time frame: Day 1
Thickness of arteria wall
Time frame: Day 1
Ratio between internal and external arteria diameter
Time frame: Day 1
Clinical characteristics at baseline
Time frame: Day 1
Punction-related adverse events
Time frame: 6 months
Duration of arterial punction
Time frame: Day 1
Duration of patient management
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Results publication: PubMed 42338037Paniego J, Boge G, Mourad M, Duflos C, Van Rens M, Ruiz R, Lorne E, Sentenac P. Ultrasound to predict radial artery catheterization failure in patients undergoing major cardiovascular surgery (UPRAC). J Vasc Access. 2026 Jun 23:11297298261455502. doi: 10.1177/11297298261455502. Online ahead of print.
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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.
Jérôme PANIEGO principal investigator
University hospital of Montpellier, Montpellier, France, 34295
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac and Aortic Surgery, run by University Hospital, Montpellier at 1 site in France.
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 4 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 5 Aug 2026. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Failure to insert a radial artery catheter (KTA) by the nurse anesthesiologists (time frame: Day 1). 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 NCT04730479, which also lists 1 linked publication.
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 5 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.