Echography to Predict Radial Artery Catheterization Failure (EPRAC)

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Recruiting
CT.gov ID
NCT04730479
Collaborator
(none)
330
1
22.5
14.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    330 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Ultrasound Prediction of Radial Arterial Catheterization Failure in Patients Undergoing Cardiac or Aortic Surgery: a Prospective Study
    Actual Study Start Date :
    Apr 15, 2021
    Anticipated Primary Completion Date :
    Oct 1, 2022
    Anticipated Study Completion Date :
    Mar 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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.

    7. 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.

    8. 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

    9. Punction-related adverse events [6 months]

      Hematoma, dissection, thrombosis, ischemia, false aneuvrysm, infection, pain.

    10. Duration of arterial punction [Day 1]

      delay between first pulse palpation and end of bandage on a functional catheter

    11. Duration of patient management [28 days]

      duration of anaesthesia, duration of presence in surgery room, length of hospital stay

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University hospital of Montpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT04730479
    Other Study ID Numbers:
    • RECHMPL20_0091
    First Posted:
    Jan 29, 2021
    Last Update Posted:
    Dec 23, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier

    Study Results

    No Results Posted as of Dec 23, 2021