Identify Coronavirus Disease by Chest X-ray

Sponsor
Assiut University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05216471
Collaborator
(none)
150
1
31
4.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: chest X-ray

Detailed Description

The pandemic related to the coronavirus is now considered one of the deadliest epidemics. The numbers of cases exponentially increased with no specific treatment, creating havoc for the health and financial systems of the world [1-6]. Wuhan, the capital city of Hubei in China, reported the earliest cases that were treated as an unusual pneumonia. With the disease progression, the World Health Organization (WHO) announced the presence of several similar cases [7, 8]. Researchers revealed that a novel strain of the family Coronaviridae is the pathogen responsible for the respiratory illness of this disease and this is simulating two previous epidemics, namely MERS (Middle Eastern respiratory syndrome) and SARS (severe acute respiratory syndrome). The disease induced by SARS-CoV-2 was labelled as COVID-19 by the International Classification of Diseases (ICD) [9]. Chest radiographs are usually of limited value in the diagnosis of early stages especially in mild disease course; however, the CT findings may be present early even before the onset of the symptoms. Chest radiographs is very helpful in the intermediate to advanced stages of COVID-19 with features of acute respiratory distress syndrome (ARDS) as well as the follow-up [10-11]. This study to determine the COVID-19 disease course and severity using chest X-ray (CXR) scoring system and correlate these with patients' age, sex, and outcome.

Study Design

Study Type:
Observational
Actual Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Diagnostic Accuracy of Chest X-ray in Coronavirus Disease 2019
Actual Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

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

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

Outcome Measures

Primary Outcome Measures

  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. [baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • Patients exceeding 30 days after positive RT-PCR .

  • Patients diagnosed with mediastinal lymphadenopathy , masses ,Tree in bud appearance ,Pneumothorax. Or Cavitation.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut University Assiut Egypt 71515

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Chair: Nagham Nabil Mahmoud, Professor, Radiodiagnosis Department - Faculty of Medicine - Assiut University
  • Study Director: 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
  • Principal Investigator: Mohamed abdelwahab Ibrahim, bachelor, Radiodiagnosis Resident, Assiut Chest Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohamed Abdelwahab Elsadek Ibrahim, Resident doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT05216471
Other Study ID Numbers:
  • x-ray in covid19
First Posted:
Jan 31, 2022
Last Update Posted:
Jan 31, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 31, 2022