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临床试验/NCT04355481
NCT04355481Unknown不适用

Study of the Dissemination of SARS-COV-2 in the Environment of Infected Patients Admitted to Intensive Care Unit

Assistance Publique - Hôpitaux de Paris3 个研究点 分布在 1 个国家目标入组 150 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
入组人数
150
试验地点
3
主要终点
Estimate the proportion of patients hospitalized in intensive care for a SARS-Cov-2 viral lung infection and contaminating their environment at 1 meter.

研究概览

简要总结

The objective of this protocol is to estimate the proportion of patients hospitalized in intensive care unit for a SARS-Cov-2 viral lung infection and contaminating their environment at 1 meter. The contamination will be assessed by quantifying the viral RNA by RT-PCR on a 600-liter air sample aspirated by a Coriolis® system. This sample will be taken within 48 hours after the confirmation of SARS-Cov-2 infection, documented by RT-PCR. In fact, the hospital hygiene measures practiced in intensive care unit in patients with viral respiratory infection are identical to those practiced in other services. These measures are possibly insufficient as evidenced by recent data related to the COVID-19 epidemic.

详细描述

Respiratory viruses are frequently responsible for acute respiratory failure which justifies hospitalization in intensive care unit. Actually, recent epidemics of emerging viruses (including COVID-19) have highlighted the possibility of air-type transmission in this specific population. Despite the fact that the risk of environmental contamination has never been objectified, It is probable that in intensive care patients, this contamination is greater than in other patients because of the gravity of the patients (greater inoculum) and the use of ventilation techniques responsible for probably increased exhaled viral expression. Defining the mode of transmission of respiratory viruses has major consequences in terms means of prevention. The "air" mode of transmission absolutely requires hospitalization in a single room and sometimes additional air treatment. The droplet transmission mode due to its short range requires simpler measures (wearing a surgical mask, no specific air treatment) and has also led to the discussion of the value of the individual room. Indeed, the use of high flow ventilation system such as "optiflow" or non-invasive ventilation, can transform a droplet risk into "air" risk. For this reason, measuring the extent of environmental contamination around infected patients in intensive care is a major issue.

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

  • Patient over 18 years old.
  • Patient admitted to intensive care unit for a low respiratory infection during which the SARS-Cov-2 virus is documented, with a positive RT-PCR in the 48 hours before taking samples.
  • Information and not opposition from the patient / or family

排除标准

  • No documentation of SARS-Cov-2 viral respiratory infection.
  • Patient under guardianship / curatorship

结局指标

主要结局

Estimate the proportion of patients hospitalized in intensive care for a SARS-Cov-2 viral lung infection and contaminating their environment at 1 meter.

时间窗: within 48 hours of the confirmation of SARS-Cov-2 infection documented by RT-PCR

The primary objective of the study will be evaluated by the proportion of patients contaminating the air 1 meter from their face. The contamination will be assessed by quantifying the viral RNA by RT-PCR on a 600-liter air sample aspirated by a Coriolis® system. This sample will be taken within 48 hours after the confirmation of SARS-Cov-2 infection, documented by RT-PCR.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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