Clinical trial NCT05080257: Prognostic Value Of Chest Ultrasound (Lung Ultrasound Score) In COVID-19 Pneumonia Patients
Official title: Prognostic Value Of Chest Ultrasound (Lung Ultrasound Score) In COVID-19 Pneumonia Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Pneumonia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Correlation between Lung Ultrasonography Score and condition severity (inflammatory markers)
timeFrame: through study completion, an average of 2 years.
measure: Mortality
timeFrame: Through study completion, an average of 2 years.
Secondary outcomes:
measure: Ventilatory support.
timeFrame: Through study completion, an average of 2 years.
measure: Duration of hospital stay
timeFrame: Through study completion, an average of 2 years.
measure: ICU Admission
timeFrame: Through study completion, an average of 2 years.
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
References: