跳至主要内容
临床试验/NCT03364634
NCT03364634已完成不适用

Intracranial Pressure After Decompressive Craniectomy

Rigshospitalet, Denmark0 个研究点目标入组 17 人开始时间: 2015年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
主要终点
Intracranial pressure variations

研究概览

简要总结

Observational study to investigate the natural course of intracranial pressure (ICP) after decompressive craniectomy (DC) using long-term telemetric ICP monitoring. Patients will have continuous ICP measurement performed during the admission to the neuro-intensive care unit (NICU) and after discharge weekly measurements sessions will be performed before and after cranioplasty.

详细描述

Several studies have investigated and documented the effect of DC in lowering ICP in intracranial hypertension following acute brain injuries, e.g. severe traumatic brain injury. But the natural course of ICP in these patients after the acute phase in the NICU has never been investigated. Clinical experience suggests that a DC affects cerebrospinal fluid circulation and ICP, e.g. causing hydrocephalus or subdural hygromas.

The aim of this observational study is to document the natural course of ICP following DC and to investigate the effect of cranioplasty on ICP. This is done by implantation of a telemetric ICP sensor and weekly follow-up monitoring sessions after discharge from the NICU until 1 month after cranioplasty. The monitoring sessions will include standardized body positions to investigate postural ICP changes before and after cranioplasty. The project will also provide experience with telemetric ICP monitoring during the acute phase in a NICU setting.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • age > 18 years
  • scheduled for a decompressive hemicraniectomy for elevated ICP or signs of intracranial herniation

排除标准

  • skin damage in the frontal area where the telemetric ICP sensor is implanted
  • lack of informed consent from next-of-kin or the patient's general practitioner

结局指标

主要结局

Intracranial pressure variations

时间窗: Weekly monitoring sessions from discharge from the neuro-intensive care unit to 1 month after cranioplasty

ICP is measured in standardized body positions to investigate postural changes after decompressive craniectomy and following cranioplasty

次要结局

未报告次要终点

研究者

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

Alexander Lilja-Cyron

MD, PhD fellow

Rigshospitalet, Denmark

相似试验