University hospital of Montpellier
Montpellier, 34295, France
Completed
NCT Number: NCT04730479
Echography to Predict Radial Artery Catheterization Failure (EPRAC)
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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.
Secondary outcomes
-
Internal radial artery diameter
Time frame: Day 1
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.
-
External radial artery diameter
Time frame: Day 1
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.
-
Internal area of the radial artery
Time frame: Day 1
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.
-
External area of the radial artery
Time frame: Day 1
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.
-
Calcification of arterial wall (yes/no)
Time frame: Day 1
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.
-
Thickness of arteria wall
Time frame: Day 1
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.
-
Ratio between internal and external arteria diameter
Time frame: Day 1
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.
-
Clinical characteristics at baseline
Time frame: Day 1
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
-
Punction-related adverse events
Time frame: 6 months
Hematoma, dissection, thrombosis, ischemia, false aneuvrysm, infection, pain.
-
Duration of arterial punction
Time frame: Day 1
delay between first pulse palpation and end of bandage on a functional catheter
-
Duration of patient management
Time frame: 28 days
duration of anaesthesia, duration of presence in surgery room, length of hospital stay
Sponsors and collaborators
Lead sponsor
University Hospital, Montpellier
Other
Registry information
Official study title
Ultrasound Prediction of Radial Arterial Catheterization Failure in Patients Undergoing Cardiac or Aortic Surgery: a Prospective Study
Acronym: EPRAC
Important dates
- Study start
- 2021
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Jan 29, 2021
- Registry last updated
- Nov 8, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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