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NCT Number: NCT07037797

Phased-Array Versus Curvilinear Probe for FAST Ultrasonography

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.

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Key information

Conditions

Chest Trauma Abdominal Injuries Abdominal Trauma Thoracic Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Order of the FAST echography

Diagnostic Test

Randomisation of the order in which probes are used

Primary outcomes

  1. Diagnostic performance

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

    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).

Secondary outcomes

  1. Performance time

    Time frame: During the FAST echography

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

  2. Professional experience in FAST echography

    Time frame: After its first inclusion

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

  3. Previous experience in FAST echography

    Time frame: After its first inclusion

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

  4. Diagnostic performance according to the area

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Gaelle LAMBERT, PhD

CONTACT

[email protected]

+33 2 33 06 74 46

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Memorial France Etats-Unis

Other

Registry information

Acronym: PAC-FAST

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2025
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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