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

NCT05080257 | Unknown DMC

• 1 other identifier: Prognostic value of LUS COVID
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to

1. 1.To study the prognostic value of LUS in COVID-19 patients.
2. 2.To assess the relation between Lung Ultrasonography Score and disease severity in COVID-19 Patients.
3. 3.To assess the relation between Lung Ultrasonography Score and mortality in COVID-19 patients.

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (2)

• 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.

• Mortality

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

  Through study completion, an average of 2 years.

Secondary Outcomes (3)

• Ventilatory support.

  Through study completion, an average of 2 years.

• Duration of hospital stay

  Through study completion, an average of 2 years.

• ICU Admission

  Through study completion, an average of 2 years.

Interventions

Lung Ultrasonography DEVICE

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Age \< 18.
• Heart Failure
• Chronic lung diseases with similar ultrasonographic findings to COVID-19 (ILD, Bronchiectasis, old T.B).

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, 71111, Egypt

RECRUITING

Related Links

• 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

Central Study Contacts

Karim O Sleem, BMBS

CONTACT

0201008955986; karimosama81@gmail.com

Mohammed S Abdel-Qader, Ph.D M.D

CONTACT

0201060507372; mohamed.saad85@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, Chest Department, Principal investigator, Medical Doctor

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 15, 2021
• Study Start: October 20, 2021
• Primary Completion: October 1, 2023
• Study Completion: February 1, 2024
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)