Echography to Predict Radial Artery Catheterization Failure (EPRAC)
- Conditions
- Cardiac and Aortic Surgery
- Registration Number
- NCT04730479
- Lead Sponsor
- University Hospital, Montpellier
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 330
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Failure to insert a radial artery catheter (KTA) by the nurse anesthesiologists 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 Outcome Measures
Name Time Method Internal radial artery diameter 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 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
Internal area of the radial artery 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 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) 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.
Punction-related adverse events 6 months Hematoma, dissection, thrombosis, ischemia, false aneuvrysm, infection, pain.
Ratio between internal and external arteria diameter 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.
Duration of arterial punction Day 1 delay between first pulse palpation and end of bandage on a functional catheter
Duration of patient management 28 days duration of anaesthesia, duration of presence in surgery room, length of hospital stay
External radial artery diameter 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 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.
Trial Locations
- Locations (1)
University hospital of Montpellier
🇫🇷Montpellier, France