NCT01824589终止4 期
Effects of Intrathoracic Pressure Regulation Therapy in Patients With Elevated Intracranial Pressure Due to Brain Injury or Intracranial Pathology
Advanced Circulatory Systems0 个研究点目标入组 1 人开始时间: 2012年8月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 主要终点
- Intracranial Pressure (ICP)
研究概览
简要总结
The purpose of this study is to demonstrate proof of clinical concept that application of the Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion Pressure (CPP) and a decrease in Intracranial Perfusion Pressure (ICP) in patients with head injury and elevated ICP, and to determine the optimal ventilation tidal volume (TV).
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 (Participant)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥15 years of age
- •intubated and mechanically ventilated on a volume controlled mode
- •head injury or other intracranial pathology with ICP of ≥15 mmHg
- •arterial line in place
- •SpO2 ≥95%
- •in ICU or about to undergo neurosurgery with planned placement of an ICP monitor
- •inclusion presents no significant delays to planned emergent neurosurgery
- •prior written informed consent
排除标准
- •cardiac or pulmonary injury impacting intrathoracic pressure
- •confirmed pneumothorax or hemothorax
- •PaO2/FiO2 <300
- •serious neck injury resulting in neck swelling with jugular venous compression
- •evidence of ongoing uncontrolled bleeding
- •respiratory disease such as COPD, interstitial lung disease, or other parenchymal or pulmonary vascular disease
- •congestive heart failure
结局指标
主要结局
Intracranial Pressure (ICP)
时间窗: 15 minutes after device is activated
Change in ICP from baseline will be compared with the ICP during 15 minutes of ITPR use.
次要结局
- Cerebral Perfusion Pressure (CPP)(15 minutes after device activation)
- Lung Compliance(baseline and immediately after device removal)
- Arterial Blood Gases (PaCO2)(15 minutes after device activation)
研究者
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