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临床试验/NCT02871063
NCT02871063已完成不适用

Effect of Altitude on the Evolution of Acute Respiratory Distress Syndrome

Guillermo Ortiz Ruiz0 个研究点目标入组 170 人开始时间: 2016年8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
170
主要终点
Incidence of Acute respiratory distress syndrome (ARDS)

研究概览

简要总结

The purpose of this piece of research is to assess the effect of altitude on the clinical evolution of ARDS. For this purpose, patients who live and receive care at sea level are compared with those who live and receive care at high altitudes. For reasons of convenience, a cut-point of 1500 meters above sea level was chosen. In addition to this, it will be sought to assess whether adjusting the cut-points for the severity categories of ARDS improves the ability to predict some adverse events, by comparison with unadjusted cut-points. The results of this research will probably be disruptive, and will provide the first information yet about the effect of altitude on ARDS; they will therefore be of great interest for the international scientific community and for the direct care of patients. A high bibliometric impact is to be expected.

详细描述

HYPOTHESIS

Physiological adaptations generated by living at high altitude modify the clinical evolution of ARDS.

OBJECTIVE

To describe the main clinical and developmental characteristics of ARDS diagnosed at altitudes greater than 1500 meters above sea level.

To compare the main clinical and developmental characteristics of ARDS diagnosed at altitudes greater than 1500 meters above sea level with those of cases diagnosed at altitudes below 1500 meters above sea level.

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
16 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Berlin definition of ARDS
  • Pa02/FiO2 ≤ 300 (not corrected for altitude)
  • Invasive mechanical ventilation
  • Age >16 years
  • Informed consent
  • The patient stayed at the same altitude for at least 40 days prior to ICUadmission
  • Exclusion criteria:
  • Pregnancy
  • Under 16 years
  • Not accept informed consent

排除标准

  • 未提供

结局指标

主要结局

Incidence of Acute respiratory distress syndrome (ARDS)

时间窗: 1 month

次要结局

  • Duration of mechanical ventilation of patients with Acute respiratory distress syndrome (ARDS)(1 month)
  • Length of ICU stay of patients with Acute respiratory distress syndrome (ARDS)(1 month)
  • Mortality of Acute respiratory distress syndrome (ARDS)(1 month)

研究者

发起方
Guillermo Ortiz Ruiz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Guillermo Ortiz Ruiz

MD PhD(c)

Red Latinoamericana de Medicina Intensiva de Altura

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