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临床试验/NCT04859881
NCT04859881已完成不适用

Risk Factors Associated With Barotrauma in COVID-19 Patients

Hospital General Ajusco Medio1 个研究点 分布在 1 个国家目标入组 262 人开始时间: 2020年4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
262
试验地点
1
主要终点
Barotrauma development

研究概览

简要总结

Barotrauma in mechanical ventilation (MV) is defined as lung damage attributable to the application of high airway pressure and is one of the potential mechanisms of ventilator-induced lung injury (VILI). Previous studies have shown an increased mortality in patients with barotrauma under MV; pneumothorax (PTX) being the most common presentation, but it can also present as pneumomediastinum (PM) with or without PTX, with extension to soft tissue as subcutaneous emphysema or even as pneumo-retroperitoneum and pneumo-scrotum.

Traditionally, underlying lung disease or age are known risk factors for non-trauma related barotrauma. However, in patients with novel coronavirus disease (COVID-19), the incidence of this complication is more common than in non-infected patients, as recently reported. Since little is known regarding which are the main risk factors for these events to develop, most pathophysiological mechanisms remain unexplained.

The aim of this study was to determine the risk factors for developing barotrauma in patients under MV with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS). Secondary objectives were to determine the incidence of barotrauma and its association with mortality.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients under MV fulfilling the Berlin definition for ARDS, with positive SARS-COV2 real time polymerase chain reaction

排除标准

  • Incomplete clinical records and other causes of extrapulmonary air

结局指标

主要结局

Barotrauma development

时间窗: During patient hospitalization, an average of one month

Diagnosis of barotrauma in patients under mechanical ventilation with COVID-19 associated Acute Respiratory Distress Syndrome

次要结局

  • Mortality(During patient hospitalization, an average of one month)

研究者

发起方
Hospital General Ajusco Medio
申办方类型
Other
责任方
Principal Investigator
主要研究者

Karla Verónica Chavez-Tostado

Head of Surgery Department

Hospital General Ajusco Medio

研究点 (1)

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