Phased-Array Versus Curvilinear Probe for FAST Ultrasonography

NCT07037797 | Not Yet Recruiting

• 2 other identifiers: RC-2024-0012024-A00914-43
• Study Type: interventional
• Target: 2,660
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chest Trauma; Abdominal Trauma

Keywords

chest trauma; abdominal trauma

Outcome Measures

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).

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

Secondary Outcomes (4)

• Performance time

  During the FAST echography

• Professional experience in FAST echography

  After its first inclusion

• Previous experience in FAST echography

  After its first inclusion

• Diagnostic performance according to the area

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

Study Arms (2)

Curvilinear probe then phased-array probe

EXPERIMENTAL

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

Diagnostic Test: Order of the FAST echography

Phased-array probe then curvilinear probe

EXPERIMENTAL

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

Diagnostic Test: Order of the FAST echography

Interventions

Order of the FAST echography DIAGNOSTIC_TEST

Randomisation of the order in which probes are used

Curvilinear probe then phased-array probe; Phased-array probe then curvilinear probe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients undergoing treatment limitation or discontinuation
• Pregnant, parturient or breast-feeding women
• Patients deprived of liberty by judicial or administrative decision

Sponsors & Collaborators

• Centre Hospitalier Memorial France Etats-Unis: lead

MeSH Terms

Conditions

Thoracic Injuries; Abdominal Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Félix AMIOT, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaelle LAMBERT, PhD

CONTACT

+33 2 33 06 74 46; recherche.clinique@ch-slo.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: June 26, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 2, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share