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

NCT07849569 | Not Yet Recruiting

• 1 other identifier: 1-10-72-73-26
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Emergency Medicine; POCUS; Abdominal Pain (AP); Acute Abdominal Pain; Ultrasound

Keywords

Point of care ultrasound; Emergency department; Emergency physician; Abdominal pain; Acute abdominal pain; Ultrasound; Bedside ultrasound; Emergency medicine; Randomized controlled trial; Multicenter trial; Diagnostic efficacy

Outcome Measures

Primary Outcomes (1)

• Correct preliminary diagnosis

  The primary outcome is the correct preliminary diagnosis, defined as agreement between the enrolling physician's preliminary diagnosis and the final adjudicated diagnosis.

  From enrollment to after 30 days

Secondary Outcomes (6)

• Inclusion of a correct diagnosis in the differential diagnosis

  From enrollment to after 30 days

• Appropriateness of next diagnostic/therapeutic step

  From enrollment and the first 24 hours

• ED length of stay

  From enrollment and til after 30 days

• ED re-attendance

  From enrollment and till after 30 days

• Number of additional diagnostic tests

  From enrollment til after 30 days

Study Arms (2)

Standard examination + Abdominal point-of-care ultrasound group (Intervention)

EXPERIMENTAL

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.

Diagnostic Test: Point of care ultrasound

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.

Interventions

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.

Standard examination + Abdominal point-of-care ultrasound group (Intervention)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Prior enrollment in the trial.
• 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).
• Prior physician assessment of the presenting abdominal complaint during the current ED visit.
• Prior ED assessment or received an abdominal ultrasound or CT scan for the same complaint, within the preceding 7 days.
• 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.
• Patients requiring immediate critical care or rapid-response team activation.

Sponsors & Collaborators

• University of Aarhus: lead
• Regionshospitalet Horsens: collaborator

Study Sites (3)

Esbjerg Akutafdeling

Esbjerg, 8700, Denmark

Location

Horsens Akutafdeling

Horsens, 8700, Denmark

Location

Køge Akutafdeling

Køge, Denmark

Location

MeSH Terms

Conditions

Abdominal Pain; Abdomen, Acute; Emergencies

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Disease Attributes; Pathologic Processes

Study Officials

• Jesper B Weile, MD., PhD

  Dansk: Offentligt hospital (inkl. universitetshospital)

  STUDY CHAIR

Central Study Contacts

Ronja L Larsen, MD

CONTACT

+4553609104; ronlar@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Abdominal point-of-care ultrasound expert panel assessing cine loop recordings for inter-rater agreement will be blinded to the enrolling physician's original findings.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

DK (3)