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

• Sponsor: Sakarya University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05402774
• Collaborator: (none)
• Enrollment: 207
• Location: 1
• Arms: 2
• Actual Duration (Months): 5
• Patients Per Site Per Month: 41.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Pain	Diagnostic Test: point-of-care ultrasound	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 207 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: a randomized, prospective, controlled studya randomized, prospective, controlled study
• Masking: Double (Care Provider, Outcomes 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.
• Primary Purpose: Diagnostic
• Official Title: Abdominal Pain Management and Point-of-care Ultrasound in the Emergency Department: a Randomized, Prospective, Controlled Study
• Actual Study Start Date: Oct 1, 2019
• Actual Primary Completion Date: Mar 1, 2020
• Actual Study Completion Date: Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: point-of-care ultrasound group	Diagnostic Test: point-of-care ultrasound; point-of-care ultrasound
No Intervention: Control group

Outcome Measures

Primary Outcome Measures

1. to measure the effect of POCUS on the Length of stay in emergency department [6 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sakarya University Training and Research Hospital	Sakarya		Turkey	54050

Sponsors and Collaborators

• Sakarya University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Necip Gökhan Güner, Emergency Medicine Specialist, Sakarya University
• ClinicalTrials.gov Identifier: NCT05402774
• Other Study ID Numbers: 16214662/050.01.04/152
• First Posted: Jun 2, 2022
• Last Update Posted: Jun 2, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Necip Gökhan Güner, Emergency Medicine Specialist, Sakarya University: Abdominal pain; Cost; Emergency department; Length of stay; point-of-care ultrasound
• Additional relevant MeSH terms: Emergencies; Abdominal Pain

Study Results

No Results Posted as of Jun 2, 2022