Point-of-Care Ultrasound for Diagnosing Abdominal Pain in the Emergency Department

NCT07849569 — Not applicable, Not yet recruiting, 508 participants, University of Aarhus

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Effect of Abdominal Point-of-care Ultrasound on Correct Preliminary Diagnosis in Adult Emergency Department Patients With Acute Abdominal Pain: Protocol for a Multicentre, Parallel-group, Randomized Superiority Trial

Registry	NCT07849569, acronym AbdoPOCUS
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, diagnostic
Enrollment	508 (Estimated)
Sponsor	University of Aarhus (Other); collaborators: Regionshospitalet Horsens
Conditions	Emergency Medicine, POCUS, Abdominal Pain (AP), Acute Abdominal Pain, Ultrasound
Interventions	Point of care ultrasound (Diagnostic test)
Dates	start 2026-10-01 (estimated), primary completion 2027-12-15 (estimated), completion 2028-08-01 (estimated), first posted 2026-09-30, last updated 2026-09-30
Locations	3 sites in Denmark

-Summary

The goal of this clinical trial is to learn if adding an abdominal ultrasound scan to the standard examination helps emergency physicians make a correct diagnosis in adults with acute abdominal pain in the emergency department. The main question it aims to answer is:

Does adding an abdominal point of care ultrasound scan to the standard examination increase the number of patients with acute abdominal pain in the emergency department, who get a correct preliminary diagnosis?

Researchers will compare patients examined with an abdominal point-of-care ultrasound scan in addition to the standard examination to patients examined with the standard examination alone, to see if adding ultrasound improves diagnostic accuracy.

Participants will:

* Be randomly assigned to also have an abdominal point-of-care ultrasound scan performed by their doctor, or not
* Have their doctor record a preliminary diagnosis and differential diagnosis
* Have their medical records reviewed by an independent panel 30 days after their visit, to determine their final diagnosis

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Standard examination + Abdominal point-of-care ultrasound group (Intervention)	Experimental	Diagnostic Test: Point of care ultrasound	Participants in the intervention group will undergo an abdominal point-of-care ultrasound examination in addition to the standard clinical examination. The scan will be performed by the enrolling physician as part of the initial bedside assessment, with timing, workflow, equipment, transducer, and preset left to the physician's discretion. The examination typically takes 5-10 minutes, and findings may guide further diagnostics or treatment, again at the physician's discretion.
Standard examination	No intervention		Participants in the control group will receive a standard clinical assessment, including uptaking the medical history and physical examination of the abdomen and, where clinically indicated, other organ systems, in line with local guidelines. Abdominal POCUS cannot be performed during the ED stay in this group. However, other POCUS modalities (e.g. lung or cardiac ultrasound) or ultrasound performed by a radiologist (after the initial assessment) may still be used if clinically indicated.

Point of care ultrasound (Diagnostic test): The abdominal point-of-care ultrasound examination is performed by the enrolling emergency physician at the bedside, as part of the initial assessment, rather than by a radiologist or sonographer. The examination follows a standardized scanning protocol developed by the study steering committee, covering conditions that are common or critical in the emergency department, accessible to point-of-care ultrasound, and supported by evidence on diagnostic accuracy. The examination typically takes 5 to 10 minutes. Findings may guide further diagnostics or treatment at the physician's discretion.

+Outcome measures

Primary outcomes

Correct preliminary diagnosis [From enrollment to after 30 days]: The primary outcome is the correct preliminary diagnosis, defined as agreement between the enrolling physician's preliminary diagnosis and the final adjudicated diagnosis.

Secondary outcomes

Inclusion of a correct diagnosis in the differential diagnosis [From enrollment to after 30 days]: The proportion of patients in whom the final adjudicated diagnosis is included in the list of differential diagnoses recorded by the physician after the initial clinical assessment.
Appropriateness of next diagnostic/therapeutic step [From enrollment and the first 24 hours]: The proportion of patients in whom the subsequent diagnostic or therapeutic step is concordant with the final diagnosis.
ED length of stay [From enrollment and til after 30 days]: Time from randomization to physical departure from the ED.
ED re-attendance [From enrollment and till after 30 days]: Re-attendance to the ED within 7 and 30 days following the index visit.
Number of additional diagnostic tests [From enrollment til after 30 days]: The number of additional diagnostic tests performed after the initial clinical assessment during the index ED visit.
Physician-reported diagnostic confidence [At enrollment]: Measured using a visual analogue scale from 0-100 following the initial clinical assessment.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. ED contact.
2. Age ≥18 years.
3. Non-traumatic, acute abdominal pain, defined as symptom onset ≤7 days prior to presentation, as chief complaint.
4. Ability to provide written informed consent, as judged by the enrolling physician, and to communicate in Danish or English.

Exclusion Criteria:

1. Prior enrollment in the trial.
2. Patients in whom the cause of the current abdominal pain is considered known at the time of enrolment (previously diagnosed condition explaining the current symptoms, e.g. known symptomatic gallstone disease).
3. Prior physician assessment of the presenting abdominal complaint during the current ED visit.
4. Prior ED assessment or received an abdominal ultrasound or CT scan for the same complaint, within the preceding 7 days.
5. Chronic abdominal pain, defined as abdominal pain persisting or recurring for ≥3 months(17), where the current episode represents an exacerbation of the chronic condition.
6. Patients requiring immediate critical care or rapid-response team activation.

+Locations (3)

Facility	City	Country
Esbjerg Akutafdeling	Esbjerg	Denmark
Horsens Akutafdeling	Horsens	Denmark
Køge Akutafdeling	Køge	Denmark

+Investigators

Jesper B Weile, MD., PhD, Study chair, Dansk: Offentligt hospital (inkl. universitetshospital)