CORonavirus (COVID-19) Diagnostic Lung UltraSound Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Diagnosis of COVID-19 on lung ultrasound
研究概览
简要总结
This observational study is designed to assess whether focused lung ultrasound examination can improve the diagnosis of COVID-19 lung disease and/or make an alternative diagnosis at a patient's initial hospital presentation. For patients with confirmed COVID-19 the study will also assess whether surveillance lung ultrasound examination can predict clinical outcome over the course of their hospital admission.
详细描述
Study participants will be screened from and recruited on their entry into the suspected COVID-19 admission pathway at Derriford Hospital, Plymouth, UK. In addition to usual clinical care (including physical exam and observations, blood tests, nasopharyngeal swab for viral PCR testing, and chest x-ray as standard), participants will undergo focused lung ultrasound examination.
Participants who are negative for COVID-19 will be followed up to confirm their final discharge diagnoses, and clinical outcome at either 3 months post-enrolment or discharge from hospital.
Participants who are positive for COVID-19 will have regular focused lung ultrasound examination during their hospital admission in addition to usual clinical care until their treatment for COVID-19 is complete. Their discharge diagnoses and clinical outcome at either 3 months post-enrolment or discharge from hospital (whichever is later).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Age greater than or equal to 18 years
- •Suspected or confirmed diagnosis of COVID-19
- •Able to provide informed consent to study participation
排除标准
- •Age less than 18 years
- •Inability to provide informed consent at the time of study enrolment
结局指标
主要结局
Diagnosis of COVID-19 on lung ultrasound
时间窗: On day of admission to hospital
Primary and blinded scorer diagnosis of COVID-19 on lung ultrasound
Difference in diagnosis of COVID-19 on lung ultrasound vs. chest x-ray
时间窗: On day of admission to hospital
Primary and blinded scorer diagnosis of COVID-19 on lung ultrasound vs. radiologist-reported chest x-ray findings
次要结局
- Ability of surveillance lung ultrasound to predict clinical trajectory / outcome in patients with COVID-19(During hospital admission)
- Consistency of lung ultrasound interpretation in patients presenting with suspected COVID-19(On day of admission to hospital)
- Diagnosis of alternative condition to COVID-19 on lung ultrasound vs. chest x-ray(On day of admission to hospital)