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The Utility of Bedside Lung Ultrasonography on Diagnosis of COVID-19

Primary Purpose

COVID, Pneumonia, Viral

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bedside lung ultrasound
Sponsored by
Kanuni Sultan Suleyman Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for COVID

Eligibility Criteria

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

Inclusion Criteria:

  • All patients with an informed consent
  • Admission to emergency department with symptoms or signs of COVID-19

Exclusion Criteria:

  • Absence of informed consent
  • Patients under age of 18
  • Presence of acute coronary syndrome
  • Presence of chronic lung disease
  • Pregnancy
  • Presence of trauma
  • Patients with a diagnosis of malignancy

Sites / Locations

  • Istanbul Kanuni Sultan Suleyman Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Suspected COVID-19 Group

Arm Description

Patients who admitted to emergency department with suspicion of COVID 19 pneumonia will be evaluated with POCUS/ bedside lung ultrasound.

Outcomes

Primary Outcome Measures

Presence of viral pneumonia caused by COVID 19
Efficacy of POCUS on diagnosis of viral pneumonia caused by COVID 19

Secondary Outcome Measures

Full Information

First Posted
May 21, 2020
Last Updated
May 21, 2020
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04399681
Brief Title
The Utility of Bedside Lung Ultrasonography on Diagnosis of COVID-19
Official Title
The Utility of Bedside Lung Ultrasonography on Diagnosis of COVID-19 at Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 10, 2020 (Actual)
Primary Completion Date
August 10, 2020 (Anticipated)
Study Completion Date
September 10, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Novel Coronavirus 2019 Disease (COVID-19) mortality is highly associated with viral pneumonia and its complications. Accurate and prompt diagnosis shown to be effective to improve outcome by providing early treatment strategies. While chest X-ray (CXR) and computerized tomography (CT) are defined as gold standard, given the advantage of being an ionized radiation free, practical technique point of care ultrasound (POCUS) is also reported as a diagnostic tool for COVID-19. There are limited studies regarding the importance of POCUS in diagnosis and review of COVID-19. Therefore the aim of this study is to evaluate the utility of bedside lung ultrasound on diagnosis of COVID-19 for patients admitted to emergency department .
Detailed Description
Novel Coronavirus 2019 Disease (COVID-19) mortality is highly associated with viral pneumonia and its complications. Accurate and prompt diagnosis shown to be effective to improve outcome by providing early treatment strategies. While chest X-ray (CXR) and computerized tomography (CT) are defined as gold standard, given the advantage of being an ionized radiation free, practical technique point of care ultrasound (POCUS) is also reported as a diagnostic tool for COVID-19. There are limited studies regarding the importance of POCUS in diagnosis and review of COVID-19. Therefore the aim of this study is to evaluate the utility of bedside lung ultrasound on diagnosis of COVID-19 for patients admitted to emergency department .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, Pneumonia, Viral

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Suspected COVID-19 Group
Arm Type
Other
Arm Description
Patients who admitted to emergency department with suspicion of COVID 19 pneumonia will be evaluated with POCUS/ bedside lung ultrasound.
Intervention Type
Device
Intervention Name(s)
Bedside lung ultrasound
Intervention Description
Point of care ultrasound will be used as bedside lung ultrasound to determine the patients if they have a COVID-19 pneumonia.
Primary Outcome Measure Information:
Title
Presence of viral pneumonia caused by COVID 19
Description
Efficacy of POCUS on diagnosis of viral pneumonia caused by COVID 19
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients with an informed consent Admission to emergency department with symptoms or signs of COVID-19 Exclusion Criteria: Absence of informed consent Patients under age of 18 Presence of acute coronary syndrome Presence of chronic lung disease Pregnancy Presence of trauma Patients with a diagnosis of malignancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ramazan Guven
Phone
+902124041500
Email
drramazanguven@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Seda Yilmaz Semerci
Phone
+905337180683
Email
sedayilmazsemerci@gmail.com
Facility Information:
Facility Name
Istanbul Kanuni Sultan Suleyman Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seda Yilmaz Semerci
Phone
+905337180683
Email
sedayilmazsemerci@gmail.com

12. IPD Sharing Statement

Learn more about this trial

The Utility of Bedside Lung Ultrasonography on Diagnosis of COVID-19

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