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

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05080257
• Collaborator: (none)
• Enrollment: 60
• Anticipated Duration (Months): 27.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Pneumonia	Device: Lung Ultrasonography

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 Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Prognostic Value Of Chest Ultrasound (Lung Ultrasound Score) In COVID-19 Pneumonia Patients
• Anticipated Study Start Date: Oct 20, 2021
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Feb 1, 2024

Outcome Measures

Primary Outcome Measures

1. 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.

2. Mortality [Through study completion, an average of 2 years.]

   creation of a statistical relation between the Lung Ultrasonography Score and mortality.

Secondary Outcome Measures

1. 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.

2. 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.

3. ICU Admission [Through study completion, an average of 2 years.]

   Assessment of relation between Lung Ultrasonography Score and the ICU admission.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• WHO dashboard for updated COVID-19 statistics
• 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

Publications

None provided.

• Responsible Party: Karim Osama Mohammed Sleem, Resident, Chest Department, Principal investigator, Medical Doctor, Assiut University
• ClinicalTrials.gov Identifier: NCT05080257
• Other Study ID Numbers: Prognostic value of LUS COVID
• First Posted: Oct 15, 2021
• Last Update Posted: Oct 15, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Pneumonia

Study Results

No Results Posted as of Oct 15, 2021