Point-of-Care Ultrasound for Diagnosing Abdominal Pain in the Emergency Department
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Point of care ultrasound
Diagnostic testThe 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.
Treatment groups
508 Participants
are divided into 2 treatment groupsGroup A: Standard examination + Abdominal point-of-care ultrasound group (Intervention)Experimental treatment 1 intervention
Group B: Standard examinationNo intervention 0 interventions
Trial outcomes
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 daysSecondary 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 days2
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 hours3
ED length of stay
Time from randomization to physical departure from the ED.
Time frame
From enrollment and til after 30 days4
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 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
Regionshospitalet Horsens
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: