PoCUS Impact on the Diagnostic Approach for Thoracic and Abdominal Pain in the ED

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain

About this trial

Many medical specialties and paramedical fields are increasingly using point-of-care ultrasound (PoCUS). In daily practice, thoracic and abdominal pain constitute a significant portion of emergency department consultations. PoCUS can be employed in various ways during thoracic and abdominal physical examinations. Most scientific societies advocate for its use to address specific clinical questions rather than to provide a definitive diagnosis.

The integration of PoCUS into clinical examinations raises the question of its effectiveness in improving the diagnostic approach, rather than its diagnostic accuracy alone. Given the broad spectrum of differential diagnoses for thoracic and abdominal pain, this multicenter prospective study protocol aims to evaluate how PoCUS enhances the diagnostic approach for patients presenting with these symptoms in the emergency department.

To assess the contribution of PoCUS, three members of an adjudication committee will blindly choose between two case report forms reporting the planned diagnostic approach for each patient: one completed before PoCUS and the other after its use by the investigator handling the case. The hypothesis that PoCUS improves the diagnostic approach by 60% will be reached if 60% of the improved diagnostic approaches favor the case report form filled out after PoCUS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

> 17 years

Thoracic or abdominal pain for less than 72 hours

Signed informed consent

Disqualifiers

Reasons making abdominal ultrasound impossible

Discovery of a pregnancy during emergency care

Follow-up impossible at one month

Trial design

Design model

Single group

Treatments tested in this trial

  • Point of care ultrasound

    Diagnostic test

    The investigator uses PoCUS to investigate thoracic or abdominal pain after anamnesis and clinical examination. The investigator reports the anamnesis, clinical examination, and PoCUS results in the patient's medical file. PoCUS images are recorded according to the procedures of the study centers and the capacities of the ultrasound machines.

Treatment groups

406 Participants
are divided into 1 treatment group
Group A: Patient with thoracic or abdominal painOther 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of superior diagnostic approaches post-PoCUS.

Percentage of superior diagnostic approaches post-PoCUS. For each patient included in the final analysis and based on the final diagnosis determined at the 1-month follow-up, three independent members of an adjudication committee will evaluate the two diagnostic approaches (pre-PoCUS and post-PoCUS) recorded in the case report forms (CRFs). The adjudication committee members will remain blinded to the intervention, ensuring they are unaware of whether the diagnostic approach occurred before or after PoCUS. For each patient, the committee, knowing the final diagnosis, will assess and determine which diagnostic approach is superior or if the two approaches are equivalent.

Time frame
From enrollment to the completion of the one-month follow-up

Secondary outcomes

1

PoCUS influence on the number of diagnoses in the differential diagnosis, on the number of treatments and on the number of complementary examination(s)

Absolute number before and after PoCUS

Time frame
From enrollment to the completion of the one-month follow-up
2

PoCUS influence on the physicians' coefficient of certainty regarding the diagnostic approach

Evaluation of % of certainty coefficient before and after PoCUS

Time frame
From enrollment to the completion of the one-month follow-up
3

PoCUS influence on the physicians' coefficient of certainty regarding the final diagnosis if this diagnosis is part of the differential diagnosis established bedside

Evaluation of % of certainty coefficient before and after PoCUS

Time frame
From enrollment to the completion of the one-month follow-up
4

PoCUS usefulness evaluated by the physician in charge

Number of PoCUS considered not useful, useful, very useful

Time frame
From enrollment to the completion of the one-month follow-up

Other outcomes

Sponsors and contacts

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