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

COVID-19 Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05080257
• Other study ID #: Prognostic value of LUS COVID
• Status: Recruiting
• Start date: October 20, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: September 2022
• Source: Assiut University
• Contact: Karim O Sleem, BMBS
• Phone: 0201008955986
• Email: karimosama81[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Pneumonia

Intervention

Device:
• Lung Ultrasonography
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)

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between Lung Ultrasonography Score and condition severity (inflammatory markers)	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.
Primary	Mortality	creation of a statistical relation between the Lung Ultrasonography Score and mortality.	Through study completion, an average of 2 years.
Secondary	Ventilatory support.	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.
Secondary	Duration of hospital stay	Assessment of relation between Lung Ultrasonography Score and the duration of hospital stay.	Through study completion, an average of 2 years.
Secondary	ICU Admission	Assessment of relation between Lung Ultrasonography Score and the ICU admission.	Through study completion, an average of 2 years.

External Links

•   2- Proposal for International Standardization of the Use of Lung Ultrasound for Patients With COVID-19, Journal of Ultrasound in Medicine, volume 39 issue 7
•   3- Brenner, D.S., Liu, G.Y., Omron, R. et al. Diagnostic accuracy of lung ultrasound for SARS-CoV-2: a retrospective cohort study. Ultrasound J 13, 12 (2021)
•   4- Faul, F., Erdfelder, E., Lang, A.-G. & Buchner, A. (2007). G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods, 39, 175-191
•   5- de Alencar, J.C.G., Marchini, J.F.M., Marino, L.O. et al. Lung ultrasound score predicts outcomes in COVID-19 patients admitted to the emergency department. Ann. Intensive Care 11, 6 (2021). https://doi.org/10.1186/s13613-020-00799-w
•   WHO dashboard for updated COVID-19 statistics