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临床试验/NCT04407468
NCT04407468已完成不适用

Awake Prone Positioning and Oxygen Therapy in Patients With COVID-19 (APRONOX)

Hospital General San Juan del Rio6 个研究点 分布在 1 个国家目标入组 827 人开始时间: 2020年5月1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
827
试验地点
6
主要终点
To analyze the relationship between the prone position and the need for orotracheal intubation.

研究概览

简要总结

The prone position strategy for patients with acute respiratory distress syndrome (ARDS) is simple and cost-effective from the first description on its use in patients with acute respiratory failure to improve hypoxemia. Different studies have investigated its safety and efficacy in various clinical settings, demonstrating that its early use in combination with non-invasive mechanical ventilation (NIV) or high-flow oxygen therapy can reduce intubation rate and mortality in ARDS. In the Coronavirus disease 2019 (COVID-19) pandemic, high-value medicine and resource optimization are critical.

详细描述

Coronavirus disease 2019 (COVID-19) is a pandemic that has significantly challenged health systems worldwide. Due to the large number of infections around the world, the implementation of strategies to reduce the number of intubations and the need for invasive mechanical ventilation becomes important. In addition to the inability of the Mexican health system to respond, patients under invasive ventilation have not had a favorable survival outcome. Up to 97% mortality has been reported in patients requiring intubation. The exact cause of this poor prognosis is not yet known. Early recognition of hypoxemic patients could help with the results. It seems reasonable in these patients to perform procedures to improve the clinical respiratory picture before intubation in less severe cases due to the aforementioned. Prone patient placement during invasive mechanical ventilation is a widespread practice in the management of severe ARDS of other etiologies. Currently, few attempts have been made to implement the prone position in patients who spontaneously ventilate with supplemental oxygen, high-flow nasal cannulas, or noninvasive mechanical ventilation. Taking into account that it is a procedure that does not require additional infrastructure within the services and does not represent an additional cost for its implementation, it becomes a valuable tool in the context of COVID-19 where intubation is associated with high mortality and in a Additionally, there are mechanical ventilator deficits in most hospitals. This work has feasibility to be carried out because it will be carried out in critical areas that have equipment and trained personnel for it in the different shifts, in addition to having patients diagnosed with COVID-19.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

To analyze the relationship between the prone position and the need for orotracheal intubation.

时间窗: 3 months

Relationship between awake prone position and the tracheal intubation

次要结局

  • The impact of the prone position on the partial oxygen saturation / inspired oxygen fraction index (SaO2 / FiO2).(3 months)

研究者

发起方
Hospital General San Juan del Rio
申办方类型
Network
责任方
Principal Investigator
主要研究者

Orlando Rubén Pérez-Nieto

Dr. Orlando Ruben Perez Nieto

Hospital General San Juan del Rio

研究点 (6)

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