Prognostic Value Of Chest Ultrasound (Lung Ultrasound Score) In COVID-19 Pneumonia Patients

September 17, 2022 updated by: Karim Osama Mohammed Sleem, Assiut University

This study aims to

  1. To study the prognostic value of LUS in COVID-19 patients.
  2. To assess the relation between Lung Ultrasonography Score and disease severity in COVID-19 Patients.
  3. To assess the relation between Lung Ultrasonography Score and mortality in COVID-19 patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

At the end of 2019, the COVID-19 pandemic broke out in Wuhan, China, and within few months -in March 2020- it was declared a pandemic by the WHO.

As of September 15th ,2021, there have been 226,844,344 confirmed cases of COVID-19, including 4,666,334 deaths, reported to WHO (1).

Due to the prevalence of COVID-19 and the financial burden it puts on the healthcare system, the use of a simple, affordable and reliable imaging modality was necessary.

The main idea in this research will be evaluating the value of Lung Ultrasonography Score in predicting the prognosis of patients with COVID-19 pneumonia and investigate the presence of a relation between the Lung Ultrasonography Score and patients' prognosis and mortality (2).

  • Currently, Lung ultrasound had sensitivity 86%, specificity 71.6%, NPV 81.7%, and PPV 77.7%. The LUS had an area under the curve of 0.84 (95% CI 0.78, 0.90). When including examinations visualizing twelve lung areas, lung US had sensitivity 90.9% and specificity 75.6%, with NPV 87.2% and PPV 82.0% and an area under the curve of 0.89 (95% CI 0.83, 0.96). (3).
  • In COVID-19 patients admitted in ED, LUS was a good predictor of death, ICU admission, and endotracheal intubation.
  • Our main strategy will be enrolling patients admitted to the chest department's isolation unit, conduct clinical examination, laboratory investigations and imaging and conduct chest ultrasonography and calculate the Lung Ultrasonography Score of the patients and create a correlation between the Lung Ultrasonography score and their prognosis and mortality.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Recruiting
        • Assiut University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Sample size calculation will be carried out using G*Power 3 software , A minimum calculated sample of 60 COVID-19 cases will be needed to detect an effect size of 0.2 (22%-70%) vs (40%-93%) in the diagnostic yield (sensitivity and specificity) of lung US in severity of COVID-19 diagnosis, with an error probability of 0.05 and 80% power on a one-tailed test

Description

Inclusion Criteria:

  • Age > 18.
  • All Confirmed COVID-19 Patients by PCR or highly suspected patients admitted to the chest department's isolation unit during the duration of the study.

Exclusion Criteria:

  • Age < 18.
  • Heart Failure
  • Chronic lung diseases with similar ultrasonographic findings to COVID-19 (ILD, Bronchiectasis, old T.B).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between Lung Ultrasonography Score and condition severity (inflammatory markers)
Time Frame: through study completion, an average of 2 years.
creation of a statistical relation between the Lung Ultrasonography Score and the severity of the condition, which is assessed by clinical examination and inflammatory markers.
through study completion, an average of 2 years.
Mortality
Time Frame: Through study completion, an average of 2 years.
creation of a statistical relation between the Lung Ultrasonography Score and mortality.
Through study completion, an average of 2 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilatory support.
Time Frame: Through study completion, an average of 2 years.
creation of a statistical relation between the Lung Ultrasonography Score and the ventilatory support needed by the patients.
Through study completion, an average of 2 years.
Duration of hospital stay
Time Frame: Through study completion, an average of 2 years.
Assessment of relation between Lung Ultrasonography Score and the duration of hospital stay.
Through study completion, an average of 2 years.
ICU Admission
Time Frame: Through study completion, an average of 2 years.
Assessment of relation between Lung Ultrasonography Score and the ICU admission.
Through study completion, an average of 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2021

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

October 6, 2021

First Submitted That Met QC Criteria

October 13, 2021

First Posted (Actual)

October 15, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 17, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prognostic value of LUS COVID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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