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

NCT06827730 | Recruiting DMC

• 1 other identifier: DATAPUS
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Abdominal Pain; Thoracic Pain

Keywords

thoracic pain; abdominal pain; point of care ultrasound; diagnostic approach

Outcome Measures

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.

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

Secondary Outcomes (7)

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

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

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

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

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

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

• PoCUS usefulness evaluated by the physician in charge

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

• Influence of PoCUS findings on the primary outcome (Positive PoCUS or negative PoCUS)

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

Study Arms (1)

Patient with thoracic or abdominal pain

OTHER

Patients presenting at the emergency department complaining of non-traumatic thoracic or abdominal pain for less than 72 hours and for whom no previous complementary examinations were performed to investigate the pain.

Diagnostic Test: Point of care ultrasound

Interventions

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.

Also known as: PoCUS

Patient with thoracic or abdominal pain

Eligibility Criteria

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

You may qualify if:

• \> 17 years
• Thoracic or abdominal pain for less than 72 hours
• Signed informed consent

You may not qualify if:

• Reasons making abdominal ultrasound impossible
• Discovery of a pregnancy during emergency care
• Follow-up impossible at one month

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead
• APHP: collaborator

Study Sites (1)

Cliniques universitaires Saint Luc

Brussels, 1200, Belgium

RECRUITING

Related Publications (12)

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  PMID: 28497416 BACKGROUND

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  PMID: 27826565 BACKGROUND

• Kohn MA, Kwan E, Gupta M, Tabas JA. Prevalence of acute myocardial infarction and other serious diagnoses in patients presenting to an urban emergency department with chest pain. J Emerg Med. 2005 Nov;29(4):383-90. doi: 10.1016/j.jemermed.2005.04.010.

  PMID: 16243193 BACKGROUND

• Atkinson P, Bowra J, Lambert M, Lamprecht H, Noble V, Jarman B. International Federation for Emergency Medicine point of care ultrasound curriculum. CJEM. 2015 Mar;17(2):161-70. doi: 10.1017/cem.2015.8.

  PMID: 26052968 BACKGROUND

• Prosch H, Radzina M, Dietrich CF, Nielsen MB, Baumann S, Ewertsen C, Jenssen C, Kabaalioglu A, Kosiak W, Kratzer W, Lim A, Popescu A, Mitkov V, Schiavone C, Wohlin M, Wustner M, Cantisani V. Ultrasound Curricula of Student Education in Europe: Summary of the Experience. Ultrasound Int Open. 2020 Jun;6(1):E25-E33. doi: 10.1055/a-1183-3009. Epub 2020 Aug 31.

  PMID: 32885138 BACKGROUND

• Nicholas E, Ly AA, Prince AM, Klawitter PF, Gaskin K, Prince LA. The Current Status of Ultrasound Education in United States Medical Schools. J Ultrasound Med. 2021 Nov;40(11):2459-2465. doi: 10.1002/jum.15633. Epub 2021 Jan 15.

  PMID: 33448471 BACKGROUND

• Cantisani V, Dietrich CF, Badea R, Dudea S, Prosch H, Cerezo E, Nuernberg D, Serra AL, Sidhu PS, Radzina M, Piscaglia F, Bachmann Nielsen M, Ewertsen C, Saftoiu A, Calliada F, Gilja OH. EFSUMB Statement on Medical Student Education in Ultrasound [long version]. Ultrasound Int Open. 2016 Mar;2(1):E2-7. doi: 10.1055/s-0035-1569413.

  PMID: 27689163 BACKGROUND

• Soucy ZP, Mills LD. American Academy of Emergency Medicine Position Statement: Ultrasound Should Be Integrated into Undergraduate Medical Education Curriculum. J Emerg Med. 2015 Jul;49(1):89-90. doi: 10.1016/j.jemermed.2014.12.092. Epub 2015 Apr 29. No abstract available.

  PMID: 25934381 BACKGROUND

• Hayward SA, Janssen J. Use of thoracic ultrasound by physiotherapists: a scoping review of the literature. Physiotherapy. 2018 Dec;104(4):367-375. doi: 10.1016/j.physio.2018.01.001. Epub 2018 Feb 2.

  PMID: 29958691 BACKGROUND

• Meadley B, Olaussen A, Delorenzo A, Roder N, Martin C, St Clair T, Burns A, Stam E, Williams B. Educational standards for training paramedics in ultrasound: a scoping review. BMC Emerg Med. 2017 Jun 17;17(1):18. doi: 10.1186/s12873-017-0131-8.

  PMID: 28623905 BACKGROUND

• Dupriez F, Niset A, Couvreur C, Marissiaux L, Gendebien F, Peyskens L, Germeau B, Fasseaux A, Rodrigues de Castro B, Penaloza A, Vanpee D, Bobbia X. Evaluation of point-of-care ultrasound use in the diagnostic approach for right upper quadrant abdominal pain management in the emergency department: a prospective study. Intern Emerg Med. 2024 Apr;19(3):803-811. doi: 10.1007/s11739-023-03480-9. Epub 2023 Dec 2.

  PMID: 38041765 BACKGROUND

• Jang T, Chauhan V, Cundiff C, Kaji AH. Assessment of emergency physician-performed ultrasound in evaluating nonspecific abdominal pain. Am J Emerg Med. 2014 May;32(5):457-60. doi: 10.1016/j.ajem.2014.01.004. Epub 2014 Jan 16.

  PMID: 24529645 BACKGROUND

MeSH Terms

Conditions

Abdominal Pain; Chest Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Florence MV Dupriez, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florence MV Dupriez, MD, PhD

CONTACT

+32 2 7647884; florence.dupriez@saintluc.uclouvain.be

Lara Absil, PhD

CONTACT

+3227641613; lara.absil@saintluc.uclouvain.be

Study Design

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

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 14, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

BE (1)