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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05080257
Enrollment
60
Registered
2021-10-15
Start date
2021-10-20
Completion date
2024-02-01
Last updated
2022-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Pneumonia

Brief summary

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.

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.

Interventions

The ultrasonography will be done using the curved probe of the SONOACE R3 SAMSUNG ultrasonography machine, SN: S0GYM3HCC00016M, manufacture date: 12-2012. Assessment of lung condition using the Lung Ultrasonography Score (total score calculated from the 12 standard examined areas, from 0 to 3 in each area, with a minimum of 0 up to 36)

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Correlation between Lung Ultrasonography Score and condition severity (inflammatory markers)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.
MortalityThrough study completion, an average of 2 years.creation of a statistical relation between the Lung Ultrasonography Score and mortality.

Secondary

MeasureTime frameDescription
Ventilatory support.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.
Duration of hospital stayThrough study completion, an average of 2 years.Assessment of relation between Lung Ultrasonography Score and the duration of hospital stay.
ICU AdmissionThrough study completion, an average of 2 years.Assessment of relation between Lung Ultrasonography Score and the ICU admission.

Countries

Egypt

Contacts

Primary ContactKarim O Sleem, BMBS
karimosama81@gmail.com0201008955986
Backup ContactMohammed S Abdel-Qader, Ph.D M.D
mohamed.saad85@yahoo.com0201060507372

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026