NCT04577235

Brief Summary

Coronavirus Disease 19 (COVID-19) pandemic has become a global health problem in a short time due to high infection rate and increasing mortality. Since it is not possible to perform thorax computed tomography (CT) and transfer of patients with COVID-19 pneumonia who are followed up in intensive care, diagnosis and follow-up by lung ultrasound (LUS) is a great advantage nowadays.The investigators aimed to evaluate the correlation between thoracic CT score and LUS score and to determine its relationship with mortality. Patients who were admitted to intensive care with the diagnosis of COVID-19 pneumonia, who had an initial thorax CT examination and who underwent LUS during admission to the intensive care unit were included in the study. The demographic characteristics, clinical parameters, prognosis, thorax CT and LUS scores of the patients were recorded prospectively. The characteristics of the survived patients and the patients who died were compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable covid19

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 5, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2020

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 6, 2020

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

2 months

First QC Date

September 29, 2020

Last Update Submit

October 5, 2020

Conditions

Keywords

COVID-19 PneumoniaCritical CareLung ultrasoundComputed tomography

Outcome Measures

Primary Outcomes (1)

  • The evaluation of the correlation between the baseline LUS score and mortality rate of patients with severe COVID-19 pneumonia who were followed up in the intensive care unit

    LUS score

    2 month

Secondary Outcomes (1)

  • The evaluation of the correlation between the baseline CT score and mortality rate of patients with severe COVID-19 pneumonia who were followed up in the intensive care unit

    2 month

Study Arms (2)

Survivors group

EXPERIMENTAL

Lung ultrasound score and computed tomography score were evaluated in the surviving group

Other: severity of lung involvement with COVID-19.

Non survivors group

EXPERIMENTAL

Lung ultrasound score and computed tomography score were evaluated in the non surviving group

Other: severity of lung involvement with COVID-19.

Interventions

transthoracic lung ultrasound and throcic CT

Non survivors groupSurvivors group

Eligibility Criteria

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

You may qualify if:

  • Over 18 years of age

You may not qualify if:

  • Under 18 years of age
  • Previous lung resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa Taksim Research and Education Hospital

Istanbul, Gazi̇osmanpaşa, 34255, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. Anaesthesiology and Reanimation

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 6, 2020

Study Start

June 5, 2020

Primary Completion

August 5, 2020

Study Completion

September 5, 2020

Last Updated

October 6, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations