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Correlation Between Thoracic Ultrasound and Thorax Computed Tomography Scores.

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
severity of lung involvement with COVID-19.
Sponsored by
Gaziosmanpasa Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for COVID-19 focused on measuring COVID-19 Pneumonia, Critical Care, Lung ultrasound, Computed tomography

Eligibility Criteria

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

Inclusion criteria:

  • Over 18 years of age

Exclusion criteria:

  • Under 18 years of age
  • Previous lung resection

Sites / Locations

  • Gaziosmanpasa Taksim Research and Education Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Survivors group

Non survivors group

Arm Description

Lung ultrasound score and computed tomography score were evaluated in the surviving group

Lung ultrasound score and computed tomography score were evaluated in the non surviving group

Outcomes

Primary Outcome Measures

The evaluation of the correlation between the baseline LUS score and mortality rate of patients with severe COVID-19 pneumonia who were followed up in the intensive care unit
LUS score

Secondary Outcome Measures

The evaluation of the correlation between the baseline CT score and mortality rate of patients with severe COVID-19 pneumonia who were followed up in the intensive care unit
CT skore

Full Information

First Posted
September 29, 2020
Last Updated
October 5, 2020
Sponsor
Gaziosmanpasa Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04577235
Brief Title
Correlation Between Thoracic Ultrasound and Thorax Computed Tomography Scores.
Official Title
Evaluation of the Correlation Between Thoracic Ultrasound and Thorax Computed Tomography Scores of Patients With Severe COVID 19 Pneumonia in Intensive Care.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 5, 2020 (Actual)
Primary Completion Date
August 5, 2020 (Actual)
Study Completion Date
September 5, 2020 (Actual)

3. Sponsor/Collaborators

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

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
Coronavirus Disease 19 (COVID-19) pandemic has become a global health problem in a short time due to high infection rate and increasing mortality. Since it is not possible to perform thorax computed tomography (CT) and transfer of patients with COVID-19 pneumonia who are followed up in intensive care, diagnosis and follow-up by lung ultrasound (LUS) is a great advantage nowadays.The investigators aimed to evaluate the correlation between thoracic CT score and LUS score and to determine its relationship with mortality. Patients who were admitted to intensive care with the diagnosis of COVID-19 pneumonia, who had an initial thorax CT examination and who underwent LUS during admission to the intensive care unit were included in the study. The demographic characteristics, clinical parameters, prognosis, thorax CT and LUS scores of the patients were recorded prospectively. The characteristics of the survived patients and the patients who died were compared.
Detailed Description
Thorax CT scoring was performed by an experienced radiologist, while LUS scoring was performed an experienced anaesthesia and reanimation specialist. The demographic characteristics, clinical parameters, prognosis, thorax CT and LUS scores of the patients were recorded prospectively. The correlation between thorax CT score and LUS score was evaluated.Lung ultrasound score (LUSS): LUS was performed by an intensive care specialist with experience in this field using a 2- to 5-MHz transducer (Esaote MyLabSeven, Getz Healthcare Malaysia). The transducer was covered with a probe cover, and the transducer and ultrasound device were cleaned with disinfectant wipes after each use. LUS examinations were performed at the bedside, in the supine position, and twelve-zone examinations were performed. Each hemithorax is separated into 6 quadrants: anterior, lateral, and posterior zones (separated by the anterior and posterior axillary lines) each divided in upper and lower portion (Figure 1). Each zone was scored according to the LUS pattern as follows: the presence of lung sliding with A-lines or fewer than two isolated B-lines, scored 0; when multiple well-defined B-lines presented, scored 1; the presence of multiple coalescent B-lines, scored 2; and when presented with a tissue pattern characterized by dynamic air bronchograms (lung consolidation), scored 3. The worst ultrasound pattern observed in each zone was recorded and used to calculate the sum of the scores (total score = 36). CT Technique and Image Interpretation The thorax CT scans in the study were obtained using the low dose protocol of our hospital with a 128-slice multi-detector CT scanner (Optima; General Electric Healthcare, Wisconsin, USA). All CT scans were performed during a single breath-hold without contrast administration. As in the ultrasound evaluation, each lung was divided into anterior, lateral and posterior quadrants based on the anterior and posterior axillary lines, and then each quadrant was divided into upper and lower sections. Each quadrant was scored between 0-3. It was scored 0 when there was no parenchymal involvement, 1score when the parenchymal involvement rate was between 0 and 33%, 2 score when it was between 33% and 66%, and 3score when it was above 66%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19 Pneumonia, Critical Care, Lung ultrasound, Computed tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Survivors group
Arm Type
Experimental
Arm Description
Lung ultrasound score and computed tomography score were evaluated in the surviving group
Arm Title
Non survivors group
Arm Type
Experimental
Arm Description
Lung ultrasound score and computed tomography score were evaluated in the non surviving group
Intervention Type
Other
Intervention Name(s)
severity of lung involvement with COVID-19.
Intervention Description
transthoracic lung ultrasound and throcic CT
Primary Outcome Measure Information:
Title
The evaluation of the correlation between the baseline LUS score and mortality rate of patients with severe COVID-19 pneumonia who were followed up in the intensive care unit
Description
LUS score
Time Frame
2 month
Secondary Outcome Measure Information:
Title
The evaluation of the correlation between the baseline CT score and mortality rate of patients with severe COVID-19 pneumonia who were followed up in the intensive care unit
Description
CT skore
Time Frame
2 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Over 18 years of age Exclusion criteria: Under 18 years of age Previous lung resection
Facility Information:
Facility Name
Gaziosmanpasa Taksim Research and Education Hospital
City
Istanbul
State/Province
Gazi̇osmanpaşa
ZIP/Postal Code
34255
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Correlation Between Thoracic Ultrasound and Thorax Computed Tomography Scores.

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