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临床试验/NCT04924816
NCT04924816已完成不适用

Evaluation of the Response to the Awake Prone Position in Patients With COVID-19

Brazilian Institute of Higher Education of Censa1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2020年7月12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
32
试验地点
1
主要终点
ICU admission rate

研究概览

简要总结

Although prone position is widely used in awake patients with COVID-19 associated with supplemental oxygenation, high flow nasal catheter, or noninvasive ventilation, few studies are attesting to its real benefits on physiological variables or intubation rate. Awake patients dependent on supplemental oxygen may have different responses to PP about peripheral oxygen saturation, heart rate, and respiratory rate. Such responses may be permanent, transient, or even absent. We believe that the response to PP can be a predictor of the need for admission to the ICU. This study aimed to evaluate the acute effects of different types of response to the prone position in patients awake with COVID-19.

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
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with a confirmed diagnosis of COVID-19, through tests based on PCR and chest tomography with suggestive findings, spontaneously ventilating, dependent on supplemental oxygen. The study included patients with: (1) age ≥ 18 years, (2) peripheral oxygen saturation less than 92% under supplemental oxygen administration equal to or greater than 6 L / min through a nasal catheter or reservoir mask; (3) no use of NIV or high-flow nasal catheter; (4) continuous monitoring with pulse oximeter; (5) mental status that allowed to follow the instructions; and (6) able to tolerate PP with minimal assistance.

排除标准

  • hemodynamic instability, severe obesity, or who were unable to tolerate and cooperate with the performance of PP

结局指标

主要结局

ICU admission rate

时间窗: Patients were followed up for up to 15 days of hospitalization.

The criteria defined for admission to the ICU included maintenance of SpO2 below 90% with oxygen flow at 15 L / min, RF greater than 30 incursions per minute, reduced level of consciousness, or clinical signs of persistent increase in respiratory work, such as paradoxical ventilatory pattern.

次要结局

未报告次要终点

研究者

发起方
Brazilian Institute of Higher Education of Censa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luciano Matos Chicayban

Laboratório de Pesquisa em Fisioterapia Pneumofuncional e Intensiva (LAPEFIPI)

Brazilian Institute of Higher Education of Censa

研究点 (1)

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