Identify Coronavirus Disease by Chest X-ray

NCT05216471 | Unknown DMC

• 1 other identifier: x-ray in covid19
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

to identify the diagnostic accuracy of chest X-ray in diagnosis of Coronavirus disease19 .

Conditions

Coronavirus Disease 2019

Outcome Measures

Primary Outcomes (1)

• sensitivity and specificity of initial CXR, where it is reported as having classic COVID-19 features in different clinical severity presentation correlation of xray finding with clinical and laboratory finding.

  to identify the accuracy of chest x-ray in diagnosis of classical covid19 according to the severity of the clinical presentation and laboratory finding

  baseline

Study Arms (3)

Mild illness

individuals who have any of the various signs and symptoms of covid-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging findings .

Radiation: chest X-ray

Moderate illness

individuals who show evidence of lower respiratory tract disease during clinical assessment or imaging and who have an oxygen saturation (SpO2) ≥94% on room air .

Radiation: chest X-ray

Severe illness

individuals who have spO2\<94% on room air, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2)\<300 mm hg, respiratory frequency\>30 breaths/min, or lung infiltrate \>50%.

Radiation: chest X-ray

Interventions

chest X-ray RADIATION

Chest Xray : postero-anterior view ,digital high resolution X-ray or ,full inspiratory

Mild illness; Moderate illness; Severe illness

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will include 150 patients with suspected COVID-19 infection with positive RT\_PCR, MSCT Chest , laboratory investigation. This sample size would be statistically significant. Each group comprises 50 patient , the radiolographic finding xray will be revising and tabulated in each one of the three group according to a standard scheme. the finding will be correlated with clinical and laboratory finding . statistic of collected data will be performed as needed .

You may qualify if:

• All individuals attending the Radiodiagnosis Department , who had paired posterior-anterior chest radiographs and RT-PCR nasopharyngeal swabs for COVID-19 at the time of initial attendance with moderate to advanced stage.
• The patients have positive finding in the posterior-anterior chest radiographs , multislice computer tomography and RT-PCR nasopharyngeal swabs for COVID-19.
• The patients with positive finding in the laboratory investigation (CBC, CRP ,ESR , S.Ferritin \& D-Dimmer) .
• Patients with positive chest-CT finding and laboratory finding despite of having negative PCR swab

You may not qualify if:

• Patients exceeding 30 days after positive RT-PCR .
• Patients diagnosed with mediastinal lymphadenopathy , masses ,Tree in bud appearance ,Pneumothorax. Or Cavitation.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

Related Publications (5)

• Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

  PMID: 32007143 BACKGROUND

• Custro N, Scafidi V, Borsellino T. [Changes in the thyroid hormone picture that may be found in severely decompensated type II diabetics]. Minerva Med. 1991 Jan-Feb;82(1-2):9-14. Italian.

  PMID: 2000180 BACKGROUND

• Litmanovich DE, Chung M, Kirkbride RR, Kicska G, Kanne JP. Review of Chest Radiograph Findings of COVID-19 Pneumonia and Suggested Reporting Language. J Thorac Imaging. 2020 Nov 1;35(6):354-360. doi: 10.1097/RTI.0000000000000541.

  PMID: 32520846 BACKGROUND

• Cheng VC, Lau SK, Woo PC, Yuen KY. Severe acute respiratory syndrome coronavirus as an agent of emerging and reemerging infection. Clin Microbiol Rev. 2007 Oct;20(4):660-94. doi: 10.1128/CMR.00023-07.

  PMID: 17934078 BACKGROUND

• Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

  PMID: 32031570 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Nagham Nabil Mahmoud, Professor

  Radiodiagnosis Department - Faculty of Medicine - Assiut University

  STUDY CHAIR

• Hosameldeen Abozaid Yousef, Associate Professor

  Radiodiagnosis Department - Faculty of Medicine - Assiut University

  STUDY DIRECTOR

• Aliaa Abd-Raboh Mohamed, Professor

  Department of Chest Diseases Faculty of Medicine - Assiut University

  STUDY DIRECTOR

• Mohamed abdelwahab Ibrahim, bachelor

  Radiodiagnosis Resident, Assiut Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: January 31, 2022
• Study Start: May 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: December 1, 2023
• Last Updated: January 31, 2022

Record last verified: 2022-01

Locations

EG (1)