跳至主要内容
临床试验/NCT02680704
NCT02680704终止不适用

Mechanical Ventilation in Severe Brain Injury: The Effect of Positive End Expiratory Pressure on Intracranial Pressure

Beth Israel Deaconess Medical Center2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2016年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
2
主要终点
Association between PEEP and ICP

研究概览

简要总结

The purpose of this study is to collect physiologic data from patients with severe brain injury who require mechanical ventilation in order to describe the impact of ventilation, specifically positive end expiratory pressure (PEEP), on intracranial pressure (ICP).

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

入选标准

  • Patients with severe brain injury (GCS 8 or less)
  • Receiving mechanical ventilation
  • Receiving intracranial pressure monitoring

排除标准

  • Esophageal varices
  • Esophageal trauma
  • Recent esophageal surgery
  • Coagulopathy (Platelets < 80k or INR> 2 )
  • Other contraindication for esophageal manometry
  • Already receiving PEEP > 15 cmH2O at enrollment
  • Intracranial hypertension (defined as ICP > 20 mmHg)
  • Decompressive hemi-craniectomy

研究组 & 干预措施

PEEP Titration Arm

Other

PEEP titrated mechanical ventilation

干预措施: PEEP titrated mechanical ventilation (Other)

结局指标

主要结局

Association between PEEP and ICP

时间窗: Change from baseline to 20 minutes

Intracranial pressure will be measured and recorded using the existing intracranial pressure monitoring device placed previously as part of the patient's routine care. The association between positive end expiratory pressure and intracranial pressure will be analyzed as the primary outcome.

次要结局

  • Association between transpulmonary pressure and ICP(Change from baseline to 20 minutes)
  • Association between PEEP and cerebral hemodynamics(Change from baseline to 20 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Valerie Banner-Goodspeed

Clinical Research Administrator

Beth Israel Deaconess Medical Center

研究点 (2)

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