The Effect of Positive End Expiratory Pressure on Intracranial Pressure: The Brain and Lung Interaction (BALI) Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in intracranial pressure
研究概览
简要总结
The purpose of this study is to understand the relationship between intracranial pressure and airway pressures during mechanical ventilation. This study is a single-center, prospective cohort study to be conducted at Beth Israel Deaconess Medical Center. The investigators will recruit patients with severe brain injury (GCS 8 or less) who receive intracranial pressure monitoring and mechanical ventilation as part of their routine medical care. The primary endpoint is the change in intracranial pressure as a function of positive end-expiratory pressure. There is only one study encounter with safety monitoring for up to 24 hours after. No additional follow up is required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patients with severe brain injury (GCS 8 or less) who receive both mechanical ventilation and intracranial pressure monitoring as part of their standard medical care will be considered eligible.
排除标准
- •Patients with esophageal varices
- •Patients with esophageal trauma
- •Patients with recent esophageal surgery
- •Patients with coagulopathy (Platelets < 80k or INR> 2 )
- •Other contraindication for esophageal manometry
- •Patients who are receiving PEEP greater than 15 cmH2O within 24 hours prior to enrollment
- •Intracranial hypertension (defined as ICP greater than 20 mmHg) within 48 hours prior to enrollment
- •Decompressive hemi-craniectomy
- •Cessation Criteria: Study related ventilator adjustments and measurements will be stopped at any point during the intervention and ventilator settings will be returned to the pre-intervention settings under the following conditions:
- •If ICP increases above 20mmHg, regardless of the duration of the event.
- •If systolic blood pressure decreases below 90mmHg, regardless of the duration of the event.
- •If systolic blood pressure increases above 180mmHg, regardless of the duration of the event.
结局指标
主要结局
Change in intracranial pressure
时间窗: Change from baseline to 20 minutes
The primary endpoint is the change in intracranial pressure as a function of positive end-expiratory pressure.
次要结局
未报告次要终点
研究者
Shahzad Shaefi
Assistant Professor of Anaesthesia
Beth Israel Deaconess Medical Center