Phased-Array Versus Curvilinear Probe for FAST Ultrasonography
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Memorial France Etats-Unis
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients undergoing treatment limitation or discontinuation
Pregnant, parturient or breast-feeding women
Patients deprived of liberty by judicial or administrative decision
Trial design
Design model
Parallel
Treatments tested in this trial
Order of the FAST echography
Diagnostic testRandomisation of the order in which probes are used
Treatment groups
2,660 Participants
are divided into 2 treatment groupsGroup A: Curvilinear probe then phased-array probeExperimental treatment 1 intervention
Group B: Phased-array probe then curvilinear probeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
1
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 echography2
Professional experience in FAST echography
The professional experience (which training) of the doctors carrying out this procedure
Time frame
After its first inclusion3
Previous experience in FAST echography
Previous ultrasound experience (how many years) of doctors performing this procedure
Time frame
After its first inclusion4
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)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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