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

Recruiting

• Conditions: COVID-19 Pneumonia

• Registration Number: NCT05080257
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-15
• Study Start: 2021-10-20
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-17
• Last Update Posted: 2022-09-21
• Primary Completion: 2023-10-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	Through study completion, an average of 2 years.	creation of a statistical relation between the Lung Ultrasonography Score and mortality.
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.

Secondary Outcome Measures

Name	Time	Method
Duration of hospital stay	Through study completion, an average of 2 years.	Assessment of relation between Lung Ultrasonography Score and the duration of hospital stay.
ICU Admission	Through study completion, an average of 2 years.	Assessment of relation between Lung Ultrasonography Score and the ICU admission.
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.

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt