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临床试验/NCT04334252
NCT04334252已完成不适用

Descriptive Study Regarding the Ambulant Screening Protocol for COVID-19 in Times of High SARS CoV-2 Prevalence

Jessa Hospital1 个研究点 分布在 1 个国家目标入组 528 人开始时间: 2020年4月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
528
试验地点
1
主要终点
Prevalence of positive Sars CoV-2 PCR

研究概览

简要总结

Descriptive prospective study to investigate the prevalence of COVID 19 during ambulant screening

详细描述

The exact prevalence of COVID-19 is unknown. Due to the relatively high number of diagnosed, symptomatic infections despite a strict policy, we expect a high prevalence of COVID 19 throughout the entire population. The risk that an asymptomatic carrier who is admitted to the hospital for a (semi)urgent surgery, treatment of investigation transfers the virus to the hospital staff is very high, and vice versa. This risk is even higher during surgery, where intubation is necessary. Therefore we would like to pre-screen all patients ambulantly on the presence of COVID 19 since there is no consensus for screening at the moment. The golden standard is the SARS CoV-2 PCR on the nasopharyngeal sample together with a CT scan of the lungs. Patients in which a bloodsample is taken as standard of care procedure in this ambulant screening will be asked to give more blood for further investigation.

On top of this standard of care screening, we will perform a questionnaire at the pre-operative visit which evaluates the possible occurence of certain symptoms in the last 2 weeks. These symptoms are fever, anorexia, cough, diarrhea, sneezing, vomiting, dyspnea, headache, rhinorrhea, loss of smell, muscle pain, sputum, sore throat and fatigue. Patients were also asked if one of their housemates are affected by these symptoms. Furthermore, 2 weeks after surgery, patient will be contacted to phone in order to fill the same questionnaire.

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

入选标准

  • All adult patients > 18 years scheduled for a (semi) urgent surgery, hematological or oncological treatment or elektrophysiciological investigations in the Jessa hospital

排除标准

  • Patients < 18 years
  • Adult patients who are unable the give informed consent
  • Language barrier

结局指标

主要结局

Prevalence of positive Sars CoV-2 PCR

时间窗: at the ambulant screening

Prevalence of positive COVID 19 tests in patients planned for surgery, treatment or investigation in the hospital

Prevalence of positive radiological findings

时间窗: at the ambulant screening

Prevalence of positive radiological findings in CT scans of the lungs of planned for surgery, treatment or investigation in the hospital

Prevalence of symptoms

时间窗: at the ambulant screening

Prevalence of fever, cough, anorexia, fatigue, diarrhea, vomiting, dyspnee, sore throat and sputum

次要结局

  • Prediction of symptoms(2 weeks after surgery or treatment)

研究者

发起方
Jessa Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ina Callebaut

dr

Jessa Hospital

研究点 (1)

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