跳至主要内容
临床试验/NCT04382235
NCT04382235已完成不适用

Management Through Non-invasive Ventilatory Support of Patients Showing an Acute Respiratory Failure Related to COVID-19 in Non-intensive Wards

University of Milano Bicocca34 个研究点 分布在 1 个国家目标入组 909 人开始时间: 2020年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
909
试验地点
34
主要终点
The number of patients treated with non-invasive ventilation devices.

研究概览

简要总结

Prospective, observational, multicenter study aiming to evaluate the number of COVID-19 pneumonia related patients treated with non-invasive ventilatory support outside the intensive care unit.

In addition, the study aims to obtain information related to the clinical characteristics and hospital results of these patients.

详细描述

In February 2020, the first case of transmission of the syndrome, indicated as COVID-19, was reported in Italy. Unfortunately, during March 2020, the syndrome spread rapidly throughout the country, affecting tens of thousands of patients, including several thousands have requested hospitalization and some hospitalization in intensive care, putting a strain on the entire regional health system.

Patients that present intermediate severity of the infection are often treated with non-invasive ventilatory support which includes high-flow nasal cannulas (HFNC), non-invasive ventilation (NIV), continuous positive airway pressure (CPAP) through face mask or helmet (helmet).

The exponential growth in the number of patients has made the massive use of these devices necessary even outside the intensive or semi-intensive wards where they are traditionally used.

Epidemiological knowledge regarding the type of patients treated with this strategy and the outcome of these patients are limited, but very important in a context of emergency.

Thus, the objective of this prospective multicenter study is to evaluate the number of patients with COVID-19 related pneumonia, treated with non-invasive ventilatory support outside the intensive care unit and to evaluate the clinical characteristics and hospital outcomes of these patients.

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

  • Age> = 18 years
  • Diagnosis of COVID-related pneumonia requiring non-invasive ventilatory support (high-flow nasal cannula, and / or non-invasive ventilation and / or CPAP)

排除标准

  • Explicit refusal to participate in the study

结局指标

主要结局

The number of patients treated with non-invasive ventilation devices.

时间窗: Until patient discharge from the hospital (approximately 5 months)

The first purpose of the study is to evaluate the number of COVID-19 related pneumonia patients treated with devices for non-invasive ventilation outside intensive care units.

次要结局

  • Incidence of organ failure(Until patient discharge from the hospital (approximately 5 months))
  • Incidence of patients requiring mechanical ventilation(Until patient discharge from the hospital (approximately 5 months))
  • Duration of hospitalization(Until patient discharge from the hospital (approximately 5 months))
  • Clinical outcome at hospital discharge(Until patient discharge from the hospital (approximately 5 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (34)

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