Echography to Predict Radial Artery Catheterization Failure (EPRAC) (EPRAC)

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.

Study Overview

• Status: Completed
• Conditions: Cardiac and Aortic Surgery

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 Type: Observational
• Enrollment (Actual): 330

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • University Hospital of Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult who have an scheduled cardiac or aortic surgery at Montpellier University Hospital

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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	Day 1
Punction-related adverse events	Hematoma, dissection, thrombosis, ischemia, false aneuvrysm, infection, pain.	6 months
Duration of arterial punction	delay between first pulse palpation and end of bandage on a functional catheter	Day 1
Duration of patient management	duration of anaesthesia, duration of presence in surgery room, length of hospital stay	28 days

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Jérôme PANIEGO, University Hospital of Montpellier, Montpellier, France, 34295

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Actual): April 6, 2022
• Study Completion (Actual): April 11, 2022

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 29, 2021

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: adult; ultrasonography; radial artery catheterization; probabilistic model
• Other Study ID Numbers: RECHMPL20_0091

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No