NCT04805684

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

March 15, 2021

Last Update Submit

March 17, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Characteristics of lesions

    6 hours

Study Arms (2)

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

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

Application of 14 areas (3 posterior, 2 lateral, and 2 anterior) lung ultrasonography protocol using the convex ultrasound probe (2-6 MHz)

lung ultrasound 14

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • and 85 years old
  • Hospitalized in intensive care unit
  • PCR (polymerase chain reaction) tested
  • Thoracic CT applied

You may not qualify if:

  • Previous lung operation
  • Thoracic wall disorder
  • Interstitial lung disease
  • Patients who did not consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PneumoniaCOVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesPneumonia, ViralVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The investigator was unaware of patient information such as medical history, PCR (polymerase chain reaction) test result, laboratory measurements, and CT scan results
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator ,Assoc. PhD. M.D.

Study Record Dates

First Submitted

March 15, 2021

First Posted

March 18, 2021

Study Start

January 1, 2021

Primary Completion

March 5, 2021

Study Completion

March 5, 2021

Last Updated

March 18, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations