Chest TraumaPAC-FASTNCT07037797
Phased-Array Versus Curvilinear Probe for FAST Ultrasonography
A study testing Order of the FAST echography in people with Chest Trauma and Abdominal Trauma, run by Centre Hospitalier Memorial France Etats-Unis.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Trauma, Abdominal Trauma
- What is being tested?
- Order of the FAST echography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,660 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 2 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients undergoing treatment limitation or discontinuation
- Pregnant, parturient or breast-feeding women
- Patients deprived of liberty by judicial or administrative decision
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Background:
FAST ultrasound is a crucial technique in emergency medicine, enabling rapid assessment of trauma patients.
Read more
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
- Being tested
- Order of the FAST echography
- Keywords
- chest trauma, abdominal trauma
- Medical subject headings
- Thoracic Injuries, Abdominal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Order of the FAST echographyDiagnostic test
Randomisation of the order in which probes are used
| Study group | Role | What they receive |
|---|---|---|
| Curvilinear probe then phased-array probe | Experimental | The first probe used is the curvilinear following by the phased-array probe Receives: 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 Receives: Diagnostic Test: Order of the FAST echography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From inclusion to the CT-scan results (which is the gold standard)
Secondary outcomes (4)
Performance time
The time taken to perform the ultrasound procedure with the phased-array probe and the curvilinear probe in seconds.
Measured: During the FAST echography
Professional experience in FAST echography
The professional experience (which training) of the doctors carrying out this procedure
Measured: After its first inclusion
Previous experience in FAST echography
Previous ultrasound experience (how many years) of doctors performing this procedure
Measured: After its first inclusion
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)
Measured: After the CT-scan results (which is the gold standard)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion2 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Memorial France Etats-Unis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Félix AMIOT, MD, Principal investigator, Hopital Mémorial France Etats-Unis - Urgences/SAMU/SMUR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037797
- Sponsor's protocol ID
- RC-2024-001
- Other IDs
- 2024-A00914-43
- Acronym
- PAC-FAST
- Status last verified
- Jun 2025
- First submitted
- 13 May 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phased-Array Versus Curvilinear Probe for FAST Ultrasonography
- ClinicalTrials.gov ID
- NCT07037797
- Acronym / sponsor ID
- PAC-FAST / RC-2024-001
- Conditions
- Chest Trauma, Abdominal Trauma
- Keywords
- chest trauma, abdominal trauma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,660 participants (estimated)
- Lead sponsor
- Centre Hospitalier Memorial France Etats-UnisUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 2 May 2027 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curvilinear probe then phased-array probe | Experimental | Diagnostic Test: Order of the FAST echographyThe first probe used is the curvilinear following by the phased-array probe |
| Phased-array probe then curvilinear probe | Experimental | Diagnostic Test: Order of the FAST echographyThe first probe used is the phased-array probe following by the curvilinear probe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients undergoing treatment limitation or discontinuation
- Pregnant, parturient or breast-feeding women
- Patients deprived of liberty by judicial or administrative decision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Order of the FAST echographyRandomisation of the order in which probes are used | Diagnostic test | Curvilinear probe then phased-array probe, Phased-array probe then curvilinear probe |
Primary outcome
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).
4 secondary outcomes
Performance time
Time frame: During the FAST echography
Professional experience in FAST echography
Time frame: After its first inclusion
Previous experience in FAST echography
Time frame: After its first inclusion
Diagnostic performance according to the area
Time frame: After the CT-scan results (which is the gold standard)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Félix AMIOT, MD principal investigator
Hopital Mémorial France Etats-Unis - Urgences/SAMU/SMUR
Questions about this trial
What is this clinical trial studying?
A study testing Order of the FAST echography in people with Chest Trauma and Abdominal Trauma, run by Centre Hospitalier Memorial France Etats-Unis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gaelle LAMBERT, PhD (+33 2 33 06 74 46, recherche.clinique@ch-slo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance (time frame: From inclusion to the CT-scan results (which is the gold standard)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.