跳至主要内容
临床试验/NCT06642532
NCT06642532招募中不适用

A Prospective Observational Study of Transcranial Doppler Ultrasound in the Assessment of Cerebral Blood Flow After Polyetheretherketone Cranioplasty

RenJi Hospital2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
2
主要终点
transcranial doppler ultrasonography parameters before and after cranioplasty

研究概览

简要总结

Polyetheretherketone has become one of the most important material choices for cranioplasty surgery. It has been shown that conventional ultrasound can be performed through the polyetheretherketone material for the examination of brain tissue and ventricular morphology. Transcranial doppler ultrasound can obtain good images of cerebral hemodynamic parameters in patients through polyetheretherketone-covered temporal window. This trial is a clinical prospective observational study in which cases treated with polyetheretherketone cranioplasty, and transcranial doppler ultrasonography is performed preoperatively and 10 days postoperatively, and data were collected mainly including bilateral hemodynamic parameters of middle cerebral artery(MCA), terminal internal carotid artery(TICA), (anterior communicating artery)ACA, and posterior cerebral artery(PCA) (Vs, Vd, Vm, PI index, RI index) from temporal window.

研究设计

研究类型
Observational
观察模型
Other
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 of 18 years or older;
  • Proposed polyetheretherketone cranioplasty;
  • Incomplete cranial bone in the lateral temporal window;
  • Signed informed consent for surgery and informed consent for research.

排除标准

  • Although cranioplasty is proposed, the cranial bone in the temporal region is intact.

结局指标

主要结局

transcranial doppler ultrasonography parameters before and after cranioplasty

时间窗: 6 months

transcranial doppler ultrasonography's hemodynamic parameters: Pulse Index(PI) of middle cerebral artery(MCA), terminal internal carotid artery(TICA), anterior communicating artery(ACA), and posterior cerebral artery(PCA) from bilateral temporal window before and after polyetheretherketone cranioplasty. PI=(Vs - Vd )/ Vm。

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

Junfeng Feng

Chief Director of Brain Injury Center

RenJi Hospital

研究点 (2)

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