Different Lung Ultrasound Imaging Protocols in COVID-19 P... | NCT04805684

Studies
Different Lung Ultrasound Imaging Protocols in COVID-19 Pneumonia

NCT04805684

Sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Status

Completed

Last Update Posted

Mar 18, 2021Actual

Enrollment

59Actual

Phase

Not Applicable

Conditions

Lung Ultrasound
Pneumonia
Covid19

Interventions

LUS Twelve area
LUS Fourteen area

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

Mar 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

Jan 1, 2021Actual

Primary Completion Date

Mar 5, 2021Actual

Completion Date

Mar 5, 2021Actual

First Submitted Date

Mar 15, 2021

First Submission Date that Met QC Criteria

Mar 17, 2021

First Posted Date

Mar 18, 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

Mar 17, 2021

Last Update Posted Date

Mar 18, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Korgün Ökmen, Principal Investigator ,Assoc. PhD. M.D., Bursa Yuksek Ihtisas Training and Research HospitalPrincipal Investigator

Lead Sponsor

Bursa Yuksek Ihtisas Training and Research HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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.

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

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lung ultrasound 12	Active Comparator	12 zone lung ultrasonography protocol	Device: LUS Twelve area
lung ultrasound 14	Active Comparator	14 zone lung ultrasonography protocol	Device: LUS Fourteen area

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LUS Twelve area	Device	Application of 12 areas (2 posterior, 2 lateral, and 2 anterior)lung ultrasonography protocol using the convex ultrasound probe (2-6 MHz)	lung ultrasound 12

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between Thoracic CT imaging results and LUS results	Lung ultrasonography will be performed within 6 hours of the Thoracic CT.	6 hours

Secondary Outcomes

Measure	Description	Time Frame
Characteristics of lesions	Identifying the characteristics of the abnormal findings detected in Thoracic CT and LUS	6 hours

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital		Bursa			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011014	Pneumonia
D000086382	COVID-19

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Single

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

Who Masked

Investigator