## Protocol Section
### Identification Module
**NCT ID:** NCT04730479

**Acronym:** EPRAC

**Brief Title:** 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

#### Organization Study ID Info
**ID:** RECHMPL20_0091
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Montpellier
### Status Module
#### Completion Date
**Date:** 2022-04-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-11-08

**Type:** ACTUAL

**Last Update Submit Date:** 2022-11-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-04-06

**Type:** ACTUAL

#### Start Date
**Date:** 2021-04-15

**Type:** ACTUAL

**Status Verified Date:** 2022-10

#### Study First Post Date
**Date:** 2021-01-29
**Type:** ACTUAL
**Study First Submit Date:** 2021-01-25
**Study First Submit QC Date:** 2021-01-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Montpellier

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Cardiac and Aortic Surgery

**Keywords:**

- ultrasonography

- radial artery catheterization

- probabilistic model

- adult

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 330

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Failure to insert a radial artery catheter (KTA) by the nurse anesthesiologists

**Time Frame:** Day 1

#### Secondary Outcomes

**Description:** 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.

**Measure:** Internal radial artery diameter

**Time Frame:** Day 1

**Description:** 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.

**Measure:** External radial artery diameter

**Time Frame:** Day 1

**Description:** 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.

**Measure:** Internal area of the radial artery

**Time Frame:** Day 1

**Description:** 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.

**Measure:** External area of the radial artery

**Time Frame:** Day 1

**Description:** 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.

**Measure:** Calcification of arterial wall (yes/no)

**Time Frame:** Day 1

**Description:** 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.

**Measure:** Thickness of arteria wall

**Time Frame:** Day 1

**Description:** 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.

**Measure:** Ratio between internal and external arteria diameter

**Time Frame:** Day 1

**Description:** 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

**Measure:** Clinical characteristics at baseline

**Time Frame:** Day 1

**Description:** Hematoma, dissection, thrombosis, ischemia, false aneuvrysm, infection, pain.

**Measure:** Punction-related adverse events

**Time Frame:** 6 months

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

**Measure:** Duration of arterial punction

**Time Frame:** Day 1

**Description:** duration of anaesthesia, duration of presence in surgery room, length of hospital stay

**Measure:** Duration of patient management

**Time Frame:** 28 days

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Adult who have an scheduled cardiac or aortic surgery at Montpellier University Hospital

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Montpellier

**Country:** France

**Facility:** University hospital of Montpellier

**Zip:** 34295

#### Overall Officials

**Official 1:**

**Affiliation:** University hospital of Montpellier, Montpellier, France, 34295

**Name:** Jérôme PANIEGO

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
