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临床试验/NCT01924507
NCT01924507Unknown不适用

Intensive Cared Bedside Sleep Medicine

Associação Fundo de Incentivo à Pesquisa2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2013年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
400
试验地点
2
主要终点
days of admission

研究概览

简要总结

The investigators aimed to evaluated the role of bedside sleep medicine in an cardiology intensive care unit. The patients will be submitted to a overnight polysomnography. Those individuals with sleep apnea will be treated with CPAP during the ICU admission. Also, the investigators will identify the factors that compromise the sleep and will act to minimize them to improve the sleep quality.

After the interventions, the investigators will evaluate if there are reduced days of hospital admission, major cardiovascular events (infarction, reinfarction, heart failure and stroke) and overall mortality.

详细描述

At the hospital discharge and after at 1, 3 and 12 months we will evaluate the occurrence of major cardiovascular events (infarction, reinfarction, heart failure and stroke) and overall mortality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • Acute myocardial infarction
  • Acute decompensated heart failure
  • Age > 18 years-old
  • Cardiology intensive care unit admission

排除标准

  • Intravenous sedation
  • Invasive mechanical ventilation
  • hemodynamic instability
  • use of intravenous vasoactive drugs
  • acute respiratory failure

结局指标

主要结局

days of admission

时间窗: 7 days

Days of admission in the cardiology intensive care unit

次要结局

  • Combination of acute myocardial infarction, reinfarction, heart failure and stroke(12 months)

研究者

发起方
Associação Fundo de Incentivo à Pesquisa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatima Dumas Cintra

MD, PhD

Associação Fundo de Incentivo à Pesquisa

研究点 (2)

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