Phased-Array Versus Curvilinear Probe for FAST Ultrasonography

N/ANot Yet RecruitingNCT07037797

Centre Hospitalier Memorial France Etats-Unis2,660 enrolled

Overview

Background: FAST ultrasound is a crucial technique in emergency medicine, enabling rapid assessment of trauma patients. By allowing visualization of an effusion in a trauma patient in a far more sensitive and specific way than clinical examination, it enables informed decisions to be made on therapeutics, technical gestures, but also the potential receiving service. Arbitrarily, FAST ultrasound is taught with the cardiac probe (phased-array) and the abdominal probe (curvilinear). The difference in use of these two probes varies according to operator and team, with no figures available. No recent study has been conducted on the possibility of better diagnostic performance of FAST with a curvilinear versus phased-array probe. Objective: The main objective of this project is to evaluate and compare the diagnostic performance of FAST ultrasound using a phased-array probe versus a curvilinear probe in the detection of effusions in trauma patients (FAST protocol). Materials and methods: Prospective, interventional, multicenter, randomized study. Hypothesis tested: FAST-ultrasound with a curvilinear probe improves diagnostic performance compared with FAST-ultrasound with a phased-array probe.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

2,660

Conditions

Chest Trauma Abdominal Trauma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Trauma patients attending emergency departments in investigating centers * Age ≥ 18 years * Indication retained for FAST-ultrasound by the emergency physician in charge of the patient * Patient affiliated to the French Social Security system or equivalent Exclusion Criteria: * Patients undergoing treatment limitation or discontinuation * Pregnant, parturient or breast-feeding women * Patients deprived of liberty by judicial or administrative decision

Outcomes

Primary Outcomes

Diagnostic performance

Diagnostic performance with sensitivity and specificity calculations for the 'curvilinear' probe and the 'phased-array' probe in the detection of an effusion in trauma patients (FAST protocol).

Time frame: From inclusion to the CT-scan results (which is the gold standard)

Secondary Outcomes

Performance time

The time taken to perform the ultrasound procedure with the phased-array probe and the curvilinear probe in seconds.

Time frame: During the FAST echography

Professional experience in FAST echography

The professional experience (which training) of the doctors carrying out this procedure

Time frame: After its first inclusion

Previous experience in FAST echography

Previous ultrasound experience (how many years) of doctors performing this procedure

Time frame: After its first inclusion

Diagnostic performance according to the area

Diagnostic performance of the procedure according to the ultrasound area explored (Morisson pouch, Kholer pouch, pelvis, pericardium, lung bases)

Time frame: After the CT-scan results (which is the gold standard)