NCT04719234

Brief Summary

Lung ultrasonography has been used for diagnosis and treatment in many departments including intensive care before the pandemic. The gold standard method for the diagnosis of pneumonia is still chest tomography. Ultrasonography, which has advantages over tomography, has also been tried to be used in covid 19 pneumonia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

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

June 15, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

January 20, 2021

Last Update Submit

January 21, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Relationship 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

Other Outcomes (1)

  • the relation of the lesions with the pleura

    6 hours

Study Arms (1)

lung ultrasound

OTHER

lung ultrasonography protocol will be applied.

Device: lung ultrasonography

Interventions

Application of 12 zone lung ultrasonography protocol using the konvex ultrasound probe (2-6 MHz)

lung ultrasound

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 tested
  • Thoracic CT applied

You may not qualify if:

  • Previous lung and thoracic wall surgery
  • Anatomically with thoracic wall disorder
  • 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

Related Publications (1)

  • Okmen K, Yildiz DK, Soyaslan E. Comparison of lung ultrasonography findings with chest computed tomography results in coronavirus (COVID-19) pneumonia. J Med Ultrason (2001). 2021 Apr;48(2):245-252. doi: 10.1007/s10396-021-01081-7. Epub 2021 Feb 26.

MeSH Terms

Conditions

PneumoniaCOVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Korgün Ökmen, Assoc. PhD.

    Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi

    PRINCIPAL INVESTIGATOR
  • Durdu Kahraman Yıldız, M.D

    Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi

    STUDY CHAIR
  • Emel Tatar Soyaslan, M.D

    Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator ,Assoc. PhD. M.D.

Study Record Dates

First Submitted

January 20, 2021

First Posted

January 22, 2021

Study Start

June 15, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations