NCT06887400

Brief Summary

Introduction and Objective: This study aimed to reveal the effect of classical triage and Bedside Focused Ultrasonography (POCUS) in addition to classical triage on diagnosis, treatment, emergency department follow-up and its relationship with triage models in patients presenting to the emergency department with abdominal pain complaints. METHOD: This randomized, controlled, prospective study was conducted with a total of 262 volunteer participants who were divided into two groups as 127 classical triage and 135 POCUS in addition to classical triage with non-traumatic abdominal pain. The decision of which participant would be included in which group was made at a 1:1 ratio using a computer-aided randomization table. The researcher did not intervene in the clinical processes in any way. In this study, the effect of POCUS application performed in addition to classical triage on clinical processes (imaging request, initial analgesia administration time, consultation request, emergency department stay and outcome) in the primary outcome and on triage systems in the secondary outcome were evaluated. IBM SPSS 21.0 software was used for statistical analysis of the data.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

February 28, 2025

Last Update Submit

March 18, 2025

Conditions

Keywords

Emergency departmentAbdominal painPOCUSTriage

Outcome Measures

Primary Outcomes (3)

  • Time to initial analgesia

    To evaluate the effect of adding the POCUS application to conventional triage on clinical processes, including imaging requests, time to initial analgesia.

    6 months

  • Request for additional medical imaging

    To evaluate the effect of adding the POCUS application to conventional triage on imaging requests.

    6 months

  • Emergency department length of stay

    To evaluate the effect of adding POCUS to conventional triage on the length of stay of patients in the emergency department.

    6 months

Other Outcomes (4)

  • POCUS diagnostic sensitivity

    6 months

  • Emergency severity index Outcome Measure

    6 months

  • Manchester Triage System Outcome Measure

    6 months

  • +1 more other outcomes

Study Arms (2)

POCUS Triage

EXPERIMENTAL

Patients are directed to the area where they will be examined in accordance with the triage category determined by abdominal POCUS, which is performed in addition to classical triage.

Other: Point of care ultrasound (POCUS)

Classical Triage

NO INTERVENTION

Patients are directed to the area where they will be examined in accordance with the triage category determined by classical triage application.

Interventions

In this study, POCUS was performed by the same emergency medicine physician who had basic and advanced USG training and at least two years of POCUS experience, in accordance with ACEP imaging protocols. A portable USG device with B-Mode, M-Mode, Color Doppler, Power Doppler, Pulsed Wave Doppler modes, and which can be used in all clinical modes with a single probe was used during the protocol application (Butterfly iQ+™, Burlington, United States). Eight abdominal points (epigastric region, right upper quadrant, right side, right lower quadrant, suprapubic region, left lower quadrant, left side and upper quadrant, umbilical region) were scanned with POCUS, the findings were recorded on the previously prepared form, the triage categories of the patients (cl) were updated and the patients were directed to the area where they would be examined with the form.

POCUS Triage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Present to the emergency room with abdominal pain
  • No history of trauma in the last 48 hours
  • Stable hemodynamics

You may not qualify if:

  • According to the 3-way triage, the color code is red
  • Being under the age of 18
  • Being pregnant
  • Having a history of trauma within the last 48 hours
  • Being morbidly obese
  • Having mental retardation
  • Having repeated emergency room visits
  • Being referred from the polyclinic to the emergency room with a diagnosis
  • Filling the study form incompletely

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya Training and Research Hospital

Sakarya, Adapazarı, 54100, Turkey (Türkiye)

Location

Related Publications (3)

  • Thamburaj R, Sivitz A. Does the use of bedside pelvic ultrasound decrease length of stay in the emergency department? Pediatr Emerg Care. 2013 Jan;29(1):67-70. doi: 10.1097/PEC.0b013e31827b53f9.

    PMID: 23283267BACKGROUND
  • Guner NG, Yurumez Y, Yucel M, Alacam M, Guner ST, Ercan B. Effects of Point-of-care Ultrasonography on the Diagnostic Process of Patients Admitted to the Emergency Department with Chest Pain: A Randomised Controlled Trial. J Coll Physicians Surg Pak. 2020 Dec;30(12):1262-1268. doi: 10.29271/jcpsp.2020.12.1262.

    PMID: 33397050BACKGROUND
  • Durgun Y, Yurumez Y, Guner NG, Aslan N, Durmus E, Kahraman Y. Abdominal Pain Management and Point-of-care Ultrasound in the Emergency Department: A Randomised, Prospective, Controlled Study. J Coll Physicians Surg Pak. 2022 Oct;32(10):1260-1265. doi: 10.29271/jcpsp.2022.10.1260.

    PMID: 36205268BACKGROUND

MeSH Terms

Conditions

Abdominal PainEmergencies

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveDisease AttributesPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor,MD

Study Record Dates

First Submitted

February 28, 2025

First Posted

March 20, 2025

Study Start

January 1, 2024

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

March 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations