NCT01824576终止不适用
Physiological Effects of Intrathoracic Pressure Regulation in Patients With Decreased Cerebral Perfusion Due to Brain Injury or Intracranial Pathology
Advanced Circulatory Systems2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2013年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change From Baseline in Cerebral Perfusion Pressure (CPP)
研究概览
简要总结
The purpose of the study is to evaluate the physiological response to application of the Intrathoracic Pressure Regulator (ITPR) in patients with compromised cerebral circulation. The study will evaluate the physiological response to intrathoracic pressure regulation (IPR) therapy in hemodynamically stable patients with compromised cerebral circulation who are on ventilatory support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •≥18 years of age
- •intubated and mechanically ventilated on a volume controlled mode
- •head injury or other intracranial pathology and compromised cerebral perfusion
- •arterial line in place or alternative with continuous pressure monitoring
- •SpO2 ≥90%
- •mean arterial pressure >55
- •admission to ICU or about to undergo neurosurgery with planned placement of an invasive intracranial pressure monitor
- •inclusion presents no significant delays to planned emergent neurosurgery
- •prior written informed consent
排除标准
- •cardiac or pulmonary injury
- •confirmed pneumothorax or hemothorax
- •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
- •marked hypertension at time of device use defined as systolic blood pressure >180 mmHg
- •congestive heart failure
- •women with positive serum or urine pregnancy test or breast feeding
研究组 & 干预措施
ITPR
Experimental
Use of the ITPR for 120 minutes.
干预措施: ITPR (Device)
结局指标
主要结局
Change From Baseline in Cerebral Perfusion Pressure (CPP)
时间窗: During 120 minutes of device use
Change from average baseline CPP compared with the average CPP during use of the ITPR.
次要结局
- Change From Baseline in Heart Rate (HR)(baseline to 15 minutes following device use)
- Change From Baseline in Systolic Blood Pressure (SBP)(baseline to15 minutes following device use)
- Change From Baseline in Pulse Pressure (PP)(baseline to 15 minutes following device use)
- Change From Baseline in End-tidal Carbon Dioxide (EtCO2)(baseline to 15 minutes following device use)
- Change From Baseline in Mean Arterial Pressure (MAP)(baseline to 15 minutes following device use)
- Change From Baseline in PaCO2(baseline and 15 minutes after device activation)
- Change From Baseline in Diastolic Blood Pressure (DBP)(baseline to 15 minutes following device use)
- Change From Baseline in Oxygen Saturation (SpO2)(basseline to 15 minutes following device use)
研究者
研究点 (2)
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