The Utility of Bedside Lung Ultrasonography on Diagnosis... | NCT04399681

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

NCT04399681

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Status

Unknown status

Last Update Posted

May 22, 2020Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

COVID
Pneumonia, Viral

Interventions

Bedside lung ultrasound

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

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 10, 2020Actual

Primary Completion Date

Aug 10, 2020Estimated

Completion Date

Sep 10, 2020Estimated

First Submitted Date

May 21, 2020

First Submission Date that Met QC Criteria

May 21, 2020

First Posted Date

May 22, 2020Actual

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

May 21, 2020

Last Update Posted Date

May 22, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ramazan Guven, Professor, Kanuni Sultan Suleyman Training and Research HospitalPrincipal Investigator

Lead Sponsor

Kanuni Sultan Suleyman Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Suspected COVID-19 Group	Other	Patients who admitted to emergency department with suspicion of COVID 19 pneumonia will be evaluated with POCUS/ bedside lung ultrasound.	Device: Bedside lung ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bedside lung ultrasound	Device	Point of care ultrasound will be used as bedside lung ultrasound to determine the patients if they have a COVID-19 pneumonia.	Suspected COVID-19 Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of viral pneumonia caused by COVID 19	Efficacy of POCUS on diagnosis of viral pneumonia caused by COVID 19	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ramazan Guven	Contact	+902124041500		drramazanguven@gmail.com
Seda Yilmaz Semerci	Contact	+905337180683		sedayilmazsemerci@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul Kanuni Sultan Suleyman Training and Research Hospital	Recruiting	Istanbul		34303	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D011024	Pneumonia, Viral

Ancestor Terms

ID	Term
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided