NCT01955785已完成不适用
Respiratory Treatment of Patients With Moderate and Severe Traumatic Brain Injury: A Randomised Comparison of Pressure Controlled Ventilation and Pressure Regulated Volume Controlled Ventilation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- ICP
研究概览
简要总结
Intracranial pressure (ICP) in patients with traumatic brain injury (TBI) is influenced by several factors of which one is arterial CO2 tension. Patient with TBI are often sedated and mechanically ventilated in order to secure a stable PaCO2. This study compares two ventilation modus; Pressure Controlled Ventilation (PC) and Pressure Regulated Volume Controlled ventilation (PRVC) in order to observe which of the two ventilation strategies results in a more stable ICP and arterial CO2 pressure (PaCO2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Informed consent obtained from the patients next-of-kin.
- •moderate or severe TBI according to Head Injury Severity Scale (Glasgow Coma Scale (GCS) score 3-13).
- •treated at the neurosurgical ICU or the main ICU at St Olav University Hospital.
- •intubated and receiving controlled mechanical ventilation.
- •continuous measurement of ICP with either an intraventricular or an intraparenchymal pressure monitor device.
- •sedation to a level of sedation corresponding to MAAS (Motor Activity Assessment Score) 0 or 1 with continuous intravenous infusions of midazolam/propofol and morphine/fentanyl/remifentanil14.
排除标准
- •Pregnancy
- •ICP above 25 mmHg
- •ongoing cerebral anti edema therapy corresponding to Step III at St Olav University Hospital therapy guideline
- •continuous external drainage of cerebrospinal fluid (CSF)
- •Clinical pulmonary condition prohibiting changes in respiratory therapy
结局指标
主要结局
ICP
时间窗: Two hours
Each study period is two hours. All patients receive several study periods (max number 6) in a N=1 design
次要结局
- PaCO2(Two hours)
研究者
研究点 (2)
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