Evaluating Safety of Transpulmonary Pressure Guided PEEP Management in Neurocritical Care Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Change in ICP Value
研究概览
简要总结
The investigators aim to demonstrate that use of transpulmonary pressure to guide PEEP management is safe in patients with possible elevations of intracranial pressure.
详细描述
Purpose: To establish safety of titrating PEEP based on transpulmonary pressure as measured by an esophageal balloon in mechanically ventilated neurosurgical patients.
Participants: Adult patients admitted to the Neuro ICU at UNC Hospital and requiring mechanical ventilation who have an intracranial pressure monitoring device in place.
Procedures (methods): All enrolled patients will have esophageal balloons placed with measurement of transpulmonary pressures. All patients will have baseline measurements recorded of intracranial pressure, cerebral perfusion pressure, and cerebral autoregulation. PEEP will then be titrated based on transpulmonary pressure measurements with recording of physiological measurements over the next hour. At the conclusion of the hour, all patients will be returned to their prior ventilator settings.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age >/= 18) admitted to the Neuro ICU of UNC Hospital requiring mechanical ventilation and with ICP monitoring in place.
排除标准
- •Pneumothorax or pneumomediastinum
- •Life expectancy < 24 hours or expected to require mechanical ventilation for < 24 hours
- •Condition that precludes placement of an esophageal balloon [esophageal or nasopharyngeal pathology preventing insertion of the esophageal balloon catheter (esophageal ulcerations, tumors, diverticulitis, bleeding varices or in patients with sinusitis, epistaxis or recent nasopharyngeal surgery), severe thrombocytopenia (platelet count < 30) or coagulopathy (INR > 3 or on oral anticoagulants).
- •Pre-enrollment ICP > 20 mm Hg
- •Pre-enrollment CPP < 60 mm Hg
- •Planned change in the external ventricular drain set point during the pre-intervention, intervention or post-intervention periods
- •Incarceration
- •Variation in ICP of > 2 cm H2O in the hour prior to intervention.
结局指标
主要结局
Change in ICP Value
时间窗: Within 5 minutes of catheter placement
The Intracranial pressure (ICP) value after intervention will be considered equivalent to the ICP before intervention if the 95% upper bound of the change is lower than the non-inferiority margin of 4 mm Hg.
次要结局
- Change in Cerebral Perfusion Pressure (CPP)(Immediately before and 5 minutes after ventilator setting change)
- Change in Mean Arterial Pressure(Immediately before and 5 minutes after ventilator setting change)