NCT00279097终止不适用
A Safety Study to Evaluate Intracranial Pressure With the Utilization of High Frequency Chest Wall Oscillation (HFCWO) Using the Vest™ on Mechanically Ventilated Neurosurgical Patients
Hill-Rom2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2006年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Intracranial pressure
研究概览
简要总结
The purpose of this study is to evaluate changes in intracranial pressure (ICP) during or immediately following high frequency chest wall oscillation (HFCWO) treatment with the Vest™ in neurosurgical subjects.
详细描述
This study is a single site safety study to evaluate changes in intracranial pressure during or immediately following HFCWO treatment with the Vest™ in neurosurgical subjects with intracranial pressure monitors having normal opening pressures and ICP less than or equal to 20 mmHg. The secondary objective of this study is to evaluate changes in arterial blood gases that may result with Vest™ therapy in ventilated patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •ICP monitor with normal opening pressure (greater than or equal to 20 mmHg)
- •On ventilator
- •Arterial line in place
- •Age equal to or greater than 18
- •Admitted to neurotrauma intensive care unit (ICU)
排除标准
- •Inability to obtain informed consent
- •Unstable spinal cord injury
- •ICP > 20 mmHg sustained for > 5 minutes
- •Hemodynamic instability within the prior 12 hours
- •Active hemoptysis
- •Hemothorax
- •New onset, unstable arrhythmia
- •Enrollment in another interventional study
- •Aneurysm that has not been clipped or coiled
- •Coagulopathic head injury subjects
结局指标
主要结局
Intracranial pressure
SpO2
Heart rate
Mean arterial pressure (MAP)
Arterial blood gases (ABGs)
次要结局
未报告次要终点
研究者
研究点 (2)
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