NCT01695603已完成不适用
Comparison of a New Automated Ventilatory Mode Named Intellivent to Standard Controlled Ventilation in Brain Injured Patients
Prof. Philippe Jolliet2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2012年3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
- 23
- 试验地点
- 2
- 主要终点
- Partial pressure of carbon dioxide
研究概览
简要总结
Comparison of the ability of a new automated ventilatory mode named Intellibrain to maintain capnia and oxgen partial pressure within predefined ranges in comparison to the control of capnia and oxgen partial pressure obtained by using standard controlled ventilation modes in brain injured patients. Comparison of the numbers of alarms and required settings modifications observed with each ventilatory mode.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Brain injury ( traumatic brain injury, subarachnoi8dal haemorrhage, intracerebral hemorrhage, ischemic stroke)
- •Glasgow coma scale of 9 or less
- •Controlled mechanical ventilation required
- •Intracranial pressure monitoring required for clinical reasons
排除标准
- •age under 16 years old
- •clinical signs of brainstem lesions
- •patients with withdrawal order or for whom organ donation is under discussion
- •major haemodynamic instability
- •High carbon dioxide alveoloarterial gradient (>10 mmHg) and/or suffering of severe hypoxemia (PaO2/FIO2 < 150 mmHg)
- •Patients included in another interventional clinical study
结局指标
主要结局
Partial pressure of carbon dioxide
The partial pressure of carbon dioxide (PaCO2) will be recorded every thirty minutes during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation
次要结局
- Number of settings modifications
- Partial pressure of oxygen
- Number of alarms generated by the ventilator
- Cerebral perfusion pressure
- Intracranial pressure
- Respiratory parameters
- Cerebral vasoreactivity
- Partial pressure of oxygen in the brain tissue if available
- Number of therapeutic actions needed to reduce intracranial pressure
研究者
Prof. Philippe Jolliet
Main investigator
University of Lausanne Hospitals
研究点 (2)
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