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临床试验/NCT06129565
NCT06129565撤回不适用

The Use of Q-Collar to Increase CSF Drainage in Low-pressure Hydrocephalus Patients

University of Kansas Medical Center0 个研究点目标入组 20 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
20
主要终点
Ventricular size

研究概览

简要总结

The investigators hypothesize that the Q-collar compression on bilateral internal jugular veins of patients with low pressure hydrocephalus will decrease venous drainage from the intracranial space, therefore increasing intracranial volume, decreasing brain compliance, and increasing CSF drainage through the shunt. This should improve persistent hydrocephalus symptoms and demonstrate improved ventricular drainage on imaging with decompressed ventricles.

详细描述

Low-pressure hydrocephalus is an entity that is rare and difficult to manage. At this institution, Dr. Paul Camarata uses a method of "neck-wrapping" in those low-pressure hydrocephalus patients that were admitted for complications with their shunt, hypothesized to decrease venous outflow from the intracranial space, increase venous pressure within the cranium and therefore increase the turgor in the brain tissue allowing for CSF to more easily be pushed out of the ventricular space and through the drain. This would relieve the hydrocephalus symptoms and reduce ventricular size on imaging. The advent of the Q-collar for reducing TBI in contact sports functions in a similar way to the "neck-wrapping" used at this institution, but via the simplified tool of the collar. It functions by compressing the internal jugular veins bilaterally to increase intracranial volume and prevent "brain slosh" that can occur in contact sports that leads to brain injury. The collar in contrast to the neck wrap occupies a smaller surface area, which the investigators hypothesize will reduce the discomfort that is commonly associated with neck wrap. Furthermore, applying this Q-collar to low pressure hydrocephalus patients that struggle with symptom management while inpatient, the investigators hypothesize that CSF drainage will improve with wearing the collar via increased intracranial volume and lower brain compliance, therefore improving persistent hydrocephalus symptoms that are limiting on patient quality of life.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • adult with low-pressure hydrocephalus, able to cranial imaging, able to provide consent or have surrogate decision maker that is able to provide it for them

排除标准

  • pediatric patients, patients that can't consent or don't have a surrogate decision maker, patients that can't get cranial imaging

结局指标

主要结局

Ventricular size

时间窗: within 4-6 weeks

change in ventricular size with Q collar treatment

Ventricular drainage

时间窗: within 4-6 weeks

Amount of ventricular drainage with Q collar treatment

次要结局

  • Change in low-pressure hydrocephalus symptoms(4-6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

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