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The Effects of Point-of-care Ultrasonography

Primary Purpose

Chest Pain

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

About this trial

This is an interventional diagnostic trial for Chest Pain focused on measuring chest pain, POCUS, length of stay, emergency department

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sakarya University Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

POCUS group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Duration of hospitalization or discharge
Average costs during the diagnosis of patients.

Secondary Outcome Measures

The rate of change in the preliminary diagnosis of physician
The Hospitalization rate
The discharge rate

Full Information

First Posted
June 5, 2020
Last Updated
June 11, 2020
Sponsor
Sakarya University
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1. Study Identification

Unique Protocol Identification Number
NCT04429698
Brief Title
The Effects of Point-of-care Ultrasonography
Official Title
The Effects of Point-of-care Ultrasonography on the Dıagnosıs Process of Patıents Who Admıtted to Emergency Department: Randomised-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
January 15, 2019 (Actual)
Study Completion Date
January 15, 2019 (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: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain
Keywords
chest pain, POCUS, length of stay, emergency department

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
POCUS group
Arm Type
Other
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Point of care ultrasonography
Intervention Description
Point-of-care Ultrasonography is an imaging method performed with ultrasound aid to facilitate rapid diagnosis and interventions during emergency intervention.
Primary Outcome Measure Information:
Title
Duration of hospitalization or discharge
Time Frame
6 months
Title
Average costs during the diagnosis of patients.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The rate of change in the preliminary diagnosis of physician
Time Frame
6 months
Title
The Hospitalization rate
Time Frame
6 months
Title
The discharge rate
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Necip G Guner, M.D.
Organizational Affiliation
Sakarya University Training and Research Hospital
Official's Role
Principal Investigator
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
30413369
Citation
Buhumaid RE, St-Cyr Bourque J, Shokoohi H, Ma IWY, Longacre M, Liteplo AS. Integrating point-of-care ultrasound in the ED evaluation of patients presenting with chest pain and shortness of breath. Am J Emerg Med. 2019 Feb;37(2):298-303. doi: 10.1016/j.ajem.2018.10.059. Epub 2018 Oct 30.
Results Reference
background
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
result
PubMed Identifier
30405993
Citation
Lamsam L, Gharahbaghian L, Lobo V. Point-of-care Ultrasonography for Detecting the Etiology of Unexplained Acute Respiratory and Chest Complaints in the Emergency Department: A Prospective Analysis. Cureus. 2018 Aug 28;10(8):e3218. doi: 10.7759/cureus.3218.
Results Reference
result
PubMed Identifier
24673672
Citation
Elikashvili I, Tay ET, Tsung JW. The effect of point-of-care ultrasonography on emergency department length of stay and computed tomography utilization in children with suspected appendicitis. Acad Emerg Med. 2014 Feb;21(2):163-70. doi: 10.1111/acem.12319.
Results Reference
result
PubMed Identifier
29110982
Citation
Lin MJ, Neuman M, Rempell R, Monuteaux M, Levy J. Point-of-Care Ultrasound is Associated With Decreased Length of Stay in Children Presenting to the Emergency Department With Soft Tissue Infection. J Emerg Med. 2018 Jan;54(1):96-101. doi: 10.1016/j.jemermed.2017.09.017. Epub 2017 Oct 27.
Results Reference
result

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The Effects of Point-of-care Ultrasonography

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