NCT05402774

Brief Summary

Background: Abdominal pain is one of the most common reasons for admission to the emergency department (ED). This study aimed to investigate the effect of point-of-care ultrasound (POCUS) performed during the initial evaluation phase of patients who presented to the ED with abdominal pain on diagnostic processes, length of stay (LOS) in ED, and hospitalization and healthcare costs. Methodology: This prospective, randomized, controlled, parallel group study was conducted with patients who presented to the Sakarya Education Research Hospital ED with abdominal pain from October 2019 to March 2020. Patients were divided randomly into two groups: control group where standard diagnostic strategies were applied and the POCUS group where POCUS was performed together with standard diagnostic strategies. All data were analyzed using IBM SPSS 21.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

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

October 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
Last Updated

June 2, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

April 18, 2022

Last Update Submit

May 30, 2022

Conditions

Keywords

Abdominal painCostEmergency departmentLength of staypoint-of-care ultrasound

Outcome Measures

Primary Outcomes (1)

  • to measure the effect of POCUS on the Length of stay in emergency department

    6 months

Secondary Outcomes (1)

  • to measure the effect of POCUS on the average cost of patients, the rate of change in the preliminary diagnosis of the physician, and hospitalization and discharge rate

    1 months after discharge or hospitalisation

Study Arms (2)

point-of-care ultrasound group

OTHER
Diagnostic Test: point-of-care ultrasound

Control group

NO INTERVENTION

Interventions

point-of-care ultrasound

point-of-care ultrasound group

Eligibility Criteria

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

You may qualify if:

  • age \>18 years
  • Patients who presented to the ED with abdominal pain
  • Nontraumatic patients

You may not qualify if:

  • permanent mental disability,
  • age \<18 years,
  • abdominal trauma within the last 24 hours,
  • pregnancy, morbid obesity, repeated admissions,
  • referral from an external center to the ED,
  • missing patient information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University Training and Research Hospital

Sakarya, 54050, Turkey (Türkiye)

Location

Related Publications (2)

  • Laursen CB, Sloth E, Lassen AT, Christensen Rd, Lambrechtsen J, Madsen PH, Henriksen DP, Davidsen JR, Rasmussen F. Point-of-care ultrasonography in patients admitted with respiratory symptoms: a single-blind, randomised controlled trial. Lancet Respir Med. 2014 Aug;2(8):638-46. doi: 10.1016/S2213-2600(14)70135-3. Epub 2014 Jul 3.

    PMID: 24998674BACKGROUND
  • 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.

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
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
At this stage, the patients were divided into two groups: POCUS was applied to patients in the POCUS group after primary clinical evaluation. This procedure was performed in the first hour after the primary clinical evaluations of the patients by evaluating the predetermined parameters in the study form for hepatobiliary, renal, and upper and lower abdominal findings. All processes and results for patients in the control group were followed without any intervention and the results were recorded in the study form.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: a randomized, prospective, controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emergency Medicine Specialist

Study Record Dates

First Submitted

April 18, 2022

First Posted

June 2, 2022

Study Start

October 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

June 2, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations