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临床试验/NCT04365959
NCT04365959已完成不适用

Study of the Feasibility and Usefulness of the Prone Position in Patients With Respiratory Distress From Covid-19 Not Intubated, in Spontaneous Breath in Oxygen Therapy or Cpap

University of Milano Bicocca1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2020年3月20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
56
试验地点
1
主要终点
Number of patients in whom the prone position caused an increase in oxygenation

研究概览

简要总结

The prone position during mechanical ventilation in patients with Acute Respiratory Distress Syndrome (ARDS) is able to improve oxygenation and thus reduce mortality. The objective of the study is to evaluate the ability of the prone position to increase the oxygenation of the patient with SARS-cov-2 pneumonia.

详细描述

BACKGROUND:

It has been shown that the prone position (PP) during mechanical ventilation (VM) in patients with Acute Respiratory Distress Syndrome (ARDS) is able to improve oxygenation and thus reduce mortality.

The reduced mortality, however, is not only caused by an increase in oxygen, but also by the ability of the PP to reduce the damage associated with mechanical ventilation (VILI).

Studies show that the benefits of PP are also present in non-intubated patients; the PP prevents the need for intubation and the consequent risk deriving from the procedure itself and from the predisposition to develop superinfections (VAP).

Moreover, a reduction in the need for intubation and therefore hospitalization in the ICU would be particularly useful in a context of great health emergency with limited resources.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age> = 18 years old or <= 75 years old
  • Diagnosis of COVID related pneumonia requiring oxygen or CPAP support

排除标准

  • pregnant patients
  • patients with impaired consciousness and / or uncooperative
  • patients with NYHA class> II
  • patients with high proBNP
  • patients with COPD
  • contraindications evidenced by the physicians

结局指标

主要结局

Number of patients in whom the prone position caused an increase in oxygenation

时间窗: Until patient discharge from the hospital (approximately 1 month after enrollment)

Measure the ability of the prone position to increase the oxygenation of the patient with SARS-cov-2 pneumonia as a lung recruitment index.

次要结局

  • The feasibility of prone position(Until patient discharge from the hospital (approximately 1 month after enrollment))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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