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临床试验/NCT05080257
NCT05080257招募中不适用

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

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Mortality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Mortality

时间窗: Through study completion, an average of 2 years.

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

Correlation between Lung Ultrasonography Score and condition severity (inflammatory markers)

时间窗: 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.

次要结局

  • Duration of hospital stay(Through study completion, an average of 2 years.)
  • ICU Admission(Through study completion, an average of 2 years.)
  • Ventilatory support.(Through study completion, an average of 2 years.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karim Osama Mohammed Sleem

Resident, Chest Department, Principal investigator, Medical Doctor

Assiut University

研究点 (1)

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