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临床试验/NCT04855162
NCT04855162已完成不适用

Use of Lung Ultrasound in Evaluating Physiological Response to Awake Self Proning

Rush University Medical Center2 个研究点 分布在 2 个国家目标入组 74 人开始时间: 2021年7月21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
74
试验地点
2
主要终点
SpO2/FiO2 pre prone in day 1

研究概览

简要总结

The primary objective of this study is to explore the physiological mechanism of awake, self proning among patients with acute hypoxemic respiratory failure induced by COVID-19, using LUS in the first three days and explore the predictive value of LUS in patients' outcome.

详细描述

Lung ultrasound (LUS) has recently gained popularity among the imaging methods to perform bedside assessment of critically ill patients to guide clinical management. LUS is a non-invasive and easy-to-perform procedure that provides precise data on lung aeration, lung recruitment, lung morphology, and lung perfusion. Studies have shown that LUS is a useful tool in monitoring lung reaeration in intubated patients diagnosed with traditional ARDS undergoing prone positioning; however there are mixed findings in terms of the use of LUS in predicting potential prone positioning response. A recent study found that the non-intubated COVID-19 patients who responded to prone positioning had more pronounced disturbances of aeration in posterior regions, however, they only investigated patients' response to the first prone positioning and the information for the patients' outcome is lacking. In our previous study with intubated COVID-19 patients, we found that patients' response to the subsequent prone positioning had higher predictive value than the response to the first prone positioning. Therefore, the primary objective of this study is to explore the physiological mechanism of awake, self proning among patients with acute hypoxemic respiratory failure induced by COVID-19, using LUS in the first three days and explore the predictive value of LUS in patients' outcome.

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

  • Adult subjects 18 years and older,
  • Confirmed COVID-19 diagnosis
  • Acute hypoxemic respiratory failure (SpO2/FiO2 or PaO2/FiO2 <300)
  • Ordered self-prone positioning per medical team

排除标准

  • Palliative care

结局指标

主要结局

SpO2/FiO2 pre prone in day 1

时间窗: pre prone in day 1

Patients' response of oxygenation using SpO2/FiO2

SpO2/FiO2 pre prone in day 3

时间窗: Pre prone in day 3

Patients' response of oxygenation using SpO2/FiO2

Lung Ultrasound Score pre prone in day 1

时间窗: Pre prone in day 1

Patients' response of oxygenation using Lung ultrasound score

Lung Ultrasound Score post prone in day 3

时间窗: Post prone in day 3

Patients' response of oxygenation using Lung ultrasound score

SpO2/FiO2 pre prone in day 2

时间窗: Pre prone in day 2

Patients' response of oxygenation using SpO2/FiO2

SpO2/FiO2 post prone in day 2

时间窗: Post prone in day 2

Patients' response of oxygenation using SpO2/FiO2

SpO2/FiO2 post prone in day 3

时间窗: Post prone in day 3

Patients' response of oxygenation using SpO2/FiO2

Lung Ultrasound Score post prone in day 2

时间窗: Post prone in day 2

Patients' response of oxygenation using Lung ultrasound score

SpO2/FiO2 post prone in day 1

时间窗: post prone in day 1

Patients' response of oxygenation using SpO2/FiO2

Lung Ultrasound Score post prone in day 1

时间窗: Post prone in day 1

Patients' response of oxygenation using Lung ultrasound score

Lung Ultrasound Score pre prone in day 2

时间窗: Pre prone in day 2

Patients' response of oxygenation using Lung ultrasound score

Lung Ultrasound Score pre prone in day 3

时间窗: Pre prone in day 3

Patients' response of oxygenation using Lung ultrasound score

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jie Li

Associate Professor

Rush University Medical Center

研究点 (2)

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