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Phased-Array Versus Curvilinear Probe for FAST Ultrasonography (PAC-FAST)

C

Centre Hospitalier Memorial France Etats-Unis

Status

Not yet enrolling

Conditions

Chest Trauma
Abdominal Trauma

Treatments

Diagnostic Test: Order of the FAST echography

Study type

Interventional

Funder types

Other

Identifiers

NCT07037797
RC-2024-001
2024-A00914-43 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

2,660 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2,660 participants in 2 patient groups

Curvilinear probe then phased-array probe
Experimental group
Description:
The first probe used is the curvilinear following by the phased-array probe
Treatment:
Diagnostic Test: Order of the FAST echography
Phased-array probe then curvilinear probe
Experimental group
Description:
The first probe used is the phased-array probe following by the curvilinear probe
Treatment:
Diagnostic Test: Order of the FAST echography

Trial contacts and locations

0

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Central trial contact

Gaelle LAMBERT, PhD

Data sourced from clinicaltrials.gov

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