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Not yet recruitingNCT07849569AbdoPOCUSUpdated Sep 30, 2026

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

An interventional study of Point of care ultrasound in Emergency Medicine, POCUS and Abdominal Pain (AP), sponsored by University of Aarhus. Not yet recruiting at 3 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by University of Aarhus · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
508
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
508 participants (estimated)

Study arms

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

    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

  • No intervention
    Standard examination

    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

  • Diagnostic testPoint of care ultrasound

    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.

05

What researchers measure

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.

    Time frame: From enrollment to after 30 days

Secondary outcomes

  1. Inclusion of a correct diagnosis in the differential diagnosis

    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.

    Time frame: From enrollment to after 30 days

  2. Appropriateness of next diagnostic/therapeutic step

    The proportion of patients in whom the subsequent diagnostic or therapeutic step is concordant with the final diagnosis.

    Time frame: From enrollment and the first 24 hours

  3. ED length of stay

    Time from randomization to physical departure from the ED.

    Time frame: From enrollment and til after 30 days

  4. ED re-attendance

    Re-attendance to the ED within 7 and 30 days following the index visit.

    Time frame: From enrollment and till after 30 days

  5. Number of additional diagnostic tests

    The number of additional diagnostic tests performed after the initial clinical assessment during the index ED visit.

    Time frame: From enrollment til after 30 days

  6. Physician-reported diagnostic confidence

    Measured using a visual analogue scale from 0-100 following the initial clinical assessment.

    Time frame: At enrollment

06

Study locations

3 sites
07

References and documents

Individual participant data

Plan to share: Yes — Upon completion of the study, individual participant data underlying the results reported in study publications will be considered for sharing. Data will only be shared with researchers who submit a methodologically sound research proposal, approved by both an independent scientific review committee and the study steering committee, and subject to relevant ethical and data protection regulations (GDPR and the Danish Data Protection Act). Requests for data access should be directed to the principal investigator.

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07849569
Lead sponsor
University of Aarhus
Collaborators
Regionshospitalet Horsens
Responsible party
Sponsor
First posted
Sep 30, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Dec 15, 2027 (estimated)
Completion
Aug 2028 (estimated)
Last update
Sep 30, 2026

Study contacts

Ronja L Larsen, MD
Contact
ronlar@rm.dk
+4553609104
Jesper B Weile, MD., PhD
study chair · Dansk: Offentligt hospital (inkl. universitetshospital)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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