The Effects of Point-of-care Ultrasonography

June 11, 2020 updated by: Necip Gökhan Güner, Sakarya University

The Effects of Point-of-care Ultrasonography on the Dıagnosıs Process of Patıents Who Admıtted to Emergency Department: Randomised-Controlled Trial

Background: When used with standard diagnostic testing, point-of-care ultrasonography (POCUS) might improve the proportion of patients admitted with chest pain (CP) who are correctly diagnosed, decrease length of stay (LOS) in emergency department (ED) and costs. We therefore assessed POCUS for the heart, lungs, aortic, hepatobiliary and deep vein in addition to the usual initial diagnostic testing in this patient population.

Methods: In a prospective, randomised-controlled, parallel-group trial in the ED at Sakarya University Training and Research Hospital, Turkey, patients (≥18 years) with CP were randomly assigned in a 1:1 ratio to a standard diagnostic strategy (control group) or to standard diagnostic strategy supplemented with POCUS (POCUS group).

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Sakarya, Turkey, 54050
        • Sakarya University Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients admitted to the emergency were included in this study if they had chest pain, or chest pain with back pain, neck and jaw pain, abdominal pain, arm pain and shortness of breath

Exclusion Criteria:

  • permanent mental disability
  • age younger than 18 years
  • having chest trauma in the last 24 hours
  • to be pregnant
  • need for urgent angiography with ST elevation myocardial infarction
  • to be referred to the ED as a diagnosis of external center
  • failure to obtain complete patient information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: POCUS group
Patients in this group underwent POCUS after primary clinical evaluation with the knowledge of their primary physician. This procedure was performed in the first hour after the patients' primary clinical evaluations to evaluate the predetermined parameters in the study form for the heart, lungs, hepatobiliary, aortic and deep veins.
Point-of-care Ultrasonography is an imaging method performed with ultrasound aid to facilitate rapid diagnosis and interventions during emergency intervention.
No Intervention: Control group
All processes and results were followed without any intervention in the processes related to the patients in this group and the results were recorded in the study form

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of hospitalization or discharge
Time Frame: 6 months
6 months
Average costs during the diagnosis of patients.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The rate of change in the preliminary diagnosis of physician
Time Frame: 6 months
6 months
The Hospitalization rate
Time Frame: 6 months
6 months
The discharge rate
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Necip G Guner, M.D., Sakarya University Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2018

Primary Completion (Actual)

January 15, 2019

Study Completion (Actual)

January 15, 2019

Study Registration Dates

First Submitted

June 5, 2020

First Submitted That Met QC Criteria

June 11, 2020

First Posted (Actual)

June 12, 2020

Study Record Updates

Last Update Posted (Actual)

June 12, 2020

Last Update Submitted That Met QC Criteria

June 11, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05 of 12.09.2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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