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Different Lung Ultrasound Imaging Protocols in COVID-19 Pneumonia

Primary Purpose

Lung Ultrasound, Pneumonia, Covid19

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
LUS Twelve area
LUS Fourteen area
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 (polymerase chain reaction) tested
  • Thoracic CT applied

Exclusion Criteria:

  • Previous lung operation
  • Thoracic wall disorder
  • Interstitial lung disease
  • 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 2

Arm Type

Active Comparator

Active Comparator

Arm Label

lung ultrasound 12

lung ultrasound 14

Arm Description

12 zone lung ultrasonography protocol

14 zone lung ultrasonography protocol

Outcomes

Primary Outcome Measures

Correlation 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
Identifying the characteristics of the abnormal findings detected in Thoracic CT and LUS

Full Information

First Posted
March 15, 2021
Last Updated
March 17, 2021
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04805684
Brief Title
Different Lung Ultrasound Imaging Protocols in COVID-19 Pneumonia
Official Title
Comparison of Two Different Lung Ultrasound Imaging Protocols in COVID -19 Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
March 5, 2021 (Actual)
Study Completion Date
March 5, 2021 (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 (LUS) is also used in COVID 19 pneumonia for diagnostic and follow-up purposes.It has been demonstrated in different studies that it can be used for pathologies in pleural and lung tissue. LUS was applied by different researchers by dividing the lungs into 12 and 14 regions and the results were shared.
Detailed Description
In our study, we aimed to determine the correlation between lung findings of COVID 19 pneumonia and thoracic tomography with the results of LUS applied to different numbers (12 versus 14) of areas.

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
Parallel Assignment
Masking
Investigator
Masking Description
The investigator was unaware of patient information such as medical history, PCR (polymerase chain reaction) test result, laboratory measurements, and CT scan results
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lung ultrasound 12
Arm Type
Active Comparator
Arm Description
12 zone lung ultrasonography protocol
Arm Title
lung ultrasound 14
Arm Type
Active Comparator
Arm Description
14 zone lung ultrasonography protocol
Intervention Type
Device
Intervention Name(s)
LUS Twelve area
Intervention Description
Application of 12 areas (2 posterior, 2 lateral, and 2 anterior)lung ultrasonography protocol using the convex ultrasound probe (2-6 MHz)
Intervention Type
Device
Intervention Name(s)
LUS Fourteen area
Intervention Description
Application of 14 areas (3 posterior, 2 lateral, and 2 anterior) lung ultrasonography protocol using the convex ultrasound probe (2-6 MHz)
Primary Outcome Measure Information:
Title
Correlation 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
Identifying the characteristics of the abnormal findings detected in Thoracic CT and LUS
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 (polymerase chain reaction) tested Thoracic CT applied Exclusion Criteria: Previous lung operation Thoracic wall disorder Interstitial lung disease Patients who did not consent to participate in the study
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

Learn more about this trial

Different Lung Ultrasound Imaging Protocols in COVID-19 Pneumonia

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