NCT00644930已完成不适用
The Efficacy of Non-Invasive Positive Pressure Ventilation in ARDS: A Controlled Cohort Study
Eskisehir Osmangazi University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2003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
- 20
- 试验地点
- 2
- 主要终点
- Intubation rate
研究概览
简要总结
Background and objective: To determine the efficacy of non-invasive positive pressure ventilation (NPPV) and its effects upon intubation rate and mortality in ARDS.
详细描述
Methods: This study was performed in the respiratory intensive care unit (ICU) at a university hospital. 20 patients who achieved the diagnostic criteria for ARDS were included. The patients were prospectively allocated into two groups: a standard therapy group and a NPPV group. Invasive mechanical ventilation indications had been determined before the study. Invasive ventilation was applied to those who in need of intubation, while those given intubation received a standard medical treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 否
入选标准
- •The following criteria indicated immediate intubation was needed:
- •Apne or respiratory pauses with loss of consciousness or gasping for breath or imminent respiratory arrest.
- •Inability to increase the patient's PaO2 to more than 40 mmHg and SpO2 to more than 80% with a FiO2>0.
- •Inability to increase the patient's pH levels above 7.35, and development of blurred consciousness and confusion (Glasgow Coma Scale <9) due to respiratory acidosis despite all the support given.
- •Instability of the patient's hemodynamic parameters (such as systolic blood pressure <80 mmHg or heart rate <50 beats/minute lasting >1 hour despite fluid resuscitation).
排除标准
- •Contraindications for NPPV include:
- •The need for urgent intubation.
- •The need for frequent aspiration due to excessive secretions (more frequent than 15 min.).
- •Inability of the patient to adapt himself / herself to the device or unwillingness to undergo NPPV.
结局指标
主要结局
Intubation rate
时间窗: 48 hours
次要结局
- Hospital mortality
研究者
研究点 (2)
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