Comparison of Chest CT Findings Related to COVID-19 With... | NCT04754633

Studies
Comparison of Chest CT Findings Related to COVID-19 With RSNA and BSTI Guidelines

NCT04754633

Sponsor

Seyhmus Kavak

Status

Completed

Last Update Posted

Feb 15, 2021Actual

Enrollment

764Actual

Phase

Not provided

Conditions

Covid19
Infection Viral
CT Scan

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Jul 20, 2020Actual

Completion Date

Jul 20, 2020Actual

First Submitted Date

Feb 10, 2021

First Submission Date that Met QC Criteria

Feb 12, 2021

First Posted Date

Feb 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2021

Last Update Posted Date

Feb 15, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Seyhmus Kavak, MD, Radiologist, Principal Investigator, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalSponsor-Investigator

Lead Sponsor

Seyhmus KavakOTHER

Collaborators

Name	Class
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To present the first admission chest computed tomography (CT) findings of patients followed up with a diagnosis of COVID-19, and to compare the two classification systems by evaluating these findings according to the BSTI and RSNA guidelines.

Detailed Description

A total of 764 adult patients who were diagnosed with COVID-19 inpatient of researchers' hospital 2020 were included in this study. The findings were recorded as typical, indeterminate, and atypical by the RSNA guidelines and as classical COVID-19, possible COVID-19, indeterminate, and non-COVID-19 by the BSTI classification. The data obtained according to both classification systems were compared with each other.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

764Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Current study evaluating the success of the guidelines recommended by RSNA and BSTI in detecting COVID-19 disease	Kappa correlation analysis was performed between radiologists in the evaluation of chest CT findings of COVID-19 disease according to BSTI and RSNA guidelines.	1st week from the moment of first admission

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Who had single negative RT-PCR
Non-optimal chest CT , insufficient data
<18 age of year
Thoracic trauma
Chest CT Negative

Exclusion Criteria:

RT-PCR positive and chest CT positive findings
At least two RT-PCR negative and chest CT positive findings
>18 age of year

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects who applied to the emergency department with the diagnosis of COVID-19 and had chest CT examination between 07.01.2020 and 07.20.2020.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sağlik Bilimleri Üniversitesi Training and Research Hospital		Diyarbakır		21600	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D014777	Virus Diseases
D018352	Coronavirus Infections

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided