Clinical trial NCT04730479: Echography to Predict Radial Artery Catheterization Failure (EPRAC)
Official title: Ultrasound Prediction of Radial Arterial Catheterization Failure in Patients Undergoing Cardiac or Aortic Surgery: a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac and Aortic Surgery
Keywords: ultrasonography
radial artery catheterization
probabilistic model
adult
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult who have an scheduled cardiac or aortic surgery at Montpellier University Hospital

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.

Eligibility criteria: 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

Primary outcomes:
measure: Failure to insert a radial artery catheter (KTA) by the nurse anesthesiologists
timeFrame: Day 1
Secondary outcomes:
measure: Internal radial artery diameter
timeFrame: Day 1
measure: External radial artery diameter
timeFrame: Day 1
measure: Internal area of the radial artery
timeFrame: Day 1
measure: External area of the radial artery
timeFrame: Day 1
measure: Calcification of arterial wall (yes/no)
timeFrame: Day 1
measure: Thickness of arteria wall
timeFrame: Day 1
measure: Ratio between internal and external arteria diameter
timeFrame: Day 1
measure: Clinical characteristics at baseline
timeFrame: Day 1
measure: Punction-related adverse events
timeFrame: 6 months
measure: Duration of arterial punction
timeFrame: Day 1
measure: Duration of patient management
timeFrame: 28 days
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital of Montpellier
Study officials:
affiliation: University hospital of Montpellier, Montpellier, France, 34295
name: Jérôme PANIEGO
role: PRINCIPAL_INVESTIGATOR
References: