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Lung Ultrasonography in COVID-19 Pneumonia

Primary Purpose

Lung Ultrasound, Pneumonia, Covid19

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
lung ultrasonography
Sponsored by
Bursa Yüksek İhtisas Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Ultrasound

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 and 85 years old
  • Hospitalized in intensive care unit
  • PCR tested
  • Thoracic CT applied

Exclusion Criteria:

  • Previous lung and thoracic wall surgery
  • Anatomically with thoracic wall disorder
  • Patients who did not consent to participate in the study

Sites / Locations

  • University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

lung ultrasound

Arm Description

lung ultrasonography protocol will be applied.

Outcomes

Primary Outcome Measures

Relationship between Thoracic CT imaging results and LUS results
Lung ultrasonography will be performed within 6 hours of the Thoracic CT.

Secondary Outcome Measures

Characteristics of lesions
İdentifying the characteristics of the abnormal findings detected in Thoracic CT and LUS

Full Information

First Posted
January 20, 2021
Last Updated
January 21, 2021
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04719234
Brief Title
Lung Ultrasonography in COVID-19 Pneumonia
Official Title
Comparison of Lung Ultrasonography Findings With Chest Computerized Tomography Results in Corona virüs (COVID-19) Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bursa Yüksek İhtisas Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Lung ultrasonography has been used for diagnosis and treatment in many departments including intensive care before the pandemic. The gold standard method for the diagnosis of pneumonia is still chest tomography. Ultrasonography, which has advantages over tomography, has also been tried to be used in covid 19 pneumonia.
Detailed Description
In this study, it was aimed to investigate the efficiency of lung ultrasonography in diagnosis of covid 19 pneumonia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Ultrasound, Pneumonia, Covid19

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
lung ultrasound
Arm Type
Other
Arm Description
lung ultrasonography protocol will be applied.
Intervention Type
Device
Intervention Name(s)
lung ultrasonography
Intervention Description
Application of 12 zone lung ultrasonography protocol using the konvex ultrasound probe (2-6 MHz)
Primary Outcome Measure Information:
Title
Relationship between Thoracic CT imaging results and LUS results
Description
Lung ultrasonography will be performed within 6 hours of the Thoracic CT.
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Characteristics of lesions
Description
İdentifying the characteristics of the abnormal findings detected in Thoracic CT and LUS
Time Frame
6 hours
Other Pre-specified Outcome Measures:
Title
the relation of the lesions with the pleura
Description
the relation of the lesions with the pleura, and their distance to the pleura.
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 and 85 years old Hospitalized in intensive care unit PCR tested Thoracic CT applied Exclusion Criteria: Previous lung and thoracic wall surgery Anatomically with thoracic wall disorder Patients who did not consent to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Korgün Ökmen, Assoc. PhD.
Organizational Affiliation
Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Durdu Kahraman Yıldız, M.D
Organizational Affiliation
Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Emel Tatar Soyaslan, M.D
Organizational Affiliation
Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
Official's Role
Study Chair
Facility Information:
Facility Name
University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
City
Bursa
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33638057
Citation
Okmen K, Yildiz DK, Soyaslan E. Comparison of lung ultrasonography findings with chest computed tomography results in coronavirus (COVID-19) pneumonia. J Med Ultrason (2001). 2021 Apr;48(2):245-252. doi: 10.1007/s10396-021-01081-7. Epub 2021 Feb 26.
Results Reference
derived

Learn more about this trial

Lung Ultrasonography in COVID-19 Pneumonia

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