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Abdominal Pain Management and Point-of-care Ultrasound in the Emergency Department

Primary Purpose

Abdominal Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
point-of-care ultrasound
Sponsored by
Sakarya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Abdominal Pain focused on measuring Abdominal pain, Cost, Emergency department, Length of stay, point-of-care ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Sakarya University Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

point-of-care ultrasound group

Control group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 18, 2022
Last Updated
May 30, 2022
Sponsor
Sakarya University
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1. Study Identification

Unique Protocol Identification Number
NCT05402774
Brief Title
Abdominal Pain Management and Point-of-care Ultrasound in the Emergency Department
Official Title
Abdominal Pain Management and Point-of-care Ultrasound in the Emergency Department: a Randomized, Prospective, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sakarya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain
Keywords
Abdominal pain, Cost, Emergency department, Length of stay, point-of-care ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a randomized, prospective, controlled study
Masking
Care ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
point-of-care ultrasound group
Arm Type
Other
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Diagnostic Test
Intervention Name(s)
point-of-care ultrasound
Intervention Description
point-of-care ultrasound
Primary Outcome Measure Information:
Title
to measure the effect of POCUS on the Length of stay in emergency department
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
Time Frame
1 months after discharge or hospitalisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age >18 years Patients who presented to the ED with abdominal pain Nontraumatic patients Exclusion Criteria: 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.
Facility Information:
Facility Name
Sakarya University Training and Research Hospital
City
Sakarya
ZIP/Postal Code
54050
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24998674
Citation
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.
Results Reference
background
PubMed Identifier
33397050
Citation
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.
Results Reference
result

Learn more about this trial

Abdominal Pain Management and Point-of-care Ultrasound in the Emergency Department

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