Phased-Array Versus Curvilinear Probe for FAST Ultrasonography

NCT ID: NCT07037797

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

2660 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2027-05-02

Brief Summary

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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.

Detailed Description

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Conditions

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Chest Trauma Abdominal Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Curvilinear probe then phased-array probe

The first probe used is the curvilinear following by the phased-array probe

Group Type EXPERIMENTAL

Order of the FAST echography

Intervention Type DIAGNOSTIC_TEST

Randomisation of the order in which probes are used

Phased-array probe then curvilinear probe

The first probe used is the phased-array probe following by the curvilinear probe

Group Type EXPERIMENTAL

Order of the FAST echography

Intervention Type DIAGNOSTIC_TEST

Randomisation of the order in which probes are used

Interventions

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Order of the FAST echography

Randomisation of the order in which probes are used

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Memorial France Etats-Unis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Félix AMIOT, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Mémorial France Etats-Unis - Urgences/SAMU/SMUR

Central Contacts

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Gaelle LAMBERT, PhD

Role: CONTACT

+33 2 33 06 74 46

Other Identifiers

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2024-A00914-43

Identifier Type: OTHER

Identifier Source: secondary_id

RC-2024-001

Identifier Type: -

Identifier Source: org_study_id

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