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临床试验/NCT05931991
NCT05931991招募中不适用

Intra-operative Evaluation of the External Ventricular Drain Catheter Position With Structured Light

Sunnybrook Health Sciences Centre1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年7月7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
15
试验地点
1
主要终点
Accuracy of the structured light computer vision system

研究概览

简要总结

The placement of external ventricular drainage (EVD) is a life-saving procedure used to relieve high pressures in the brain. Often performed at the bedside, a small tube (catheter) is inserted into one ventricle of the brain to drain cerebrospinal fluid and release the pressure build up. In standard practice, EVDs are placed freehand and initial catheter malpositioning occurs in up to ~60% of procedures. Currently, there are no adequate means to verify the position of the catheter before insertion which is a significant impediment to ensure accurate positioning. This non-interventional study aims to validate a novel technology, Bullseye EVD, for verifying the position of the EVD catheter during these emergency procedures.

详细描述

External ventricular drainage (EVD) is a life-saving procedure used to release cerebrospinal fluid and relieve elevated intracranial pressure due to acute hydrocephalus, often secondary to subarachnoid hemorrhage, spontaneous intracerebral hemorrhage or traumatic brain injury (TBI). To drain cerebrospinal fluid (CSF) from the ventricular system and relieve pressure on the brain, a catheter is inserted into the ipsilateral frontal horn of the lateral ventricle (IFHLV) close to the Foramen of Monro (FoM). Twist-drill trephination is utilized to create a frontal burr hole at Kocher's point, approximately 11.5cm superior to the nasion and 2-3cm lateral of the midline. The dura is perforated, and the catheter is inserted with a rigid stylus. The current standard of care is a freehand technique which is often performed by neurosurgeons at the bedside in the ICU. It relies on surface anatomical landmarks to guide the catheter trajectory towards the FoM perpendicular to the calvarial slope at Kocher's point. However, the freehand technique is challenging to accurately perform, often requiring multiple passes of the catheter through the brain, with trajectory deviation most critical to malpositioning. Up to 24% of malpositioned EVDs require revision or reinsertion which can significantly increase catheter-associated infection. Up to 45.5% of EVD procedures require multiple passes for successful catheter insertion (6). This can lead to hemorrhage along the catheter tract (up to 34%, catheter dysfunction (up to 38%, and catheter-associated infection (up to 36% which increase EVD-associated health care costs (up to 20%). EVD malpositioning outside of the IFHLV (up to 60%) has been associated with other rare but significant complications including coma and diabetes insipidus. Large deviations in catheter placement have resulted in catheter insertion into significant brain regions (thalamus, hypothalamus, basal ganglion, internal capsule. Angular error within the coronal plane is the primary determinant of successful catheter insertion.

Bullseye is a novel intra-procedural system the investigators initially developed for glenoid guidepin placement. Bullseye EVD uses a verification workflow (guess and check) to identify EVD catheter position and trajectory with reference to the diagnostic CT image prior to catheter insertion using structured-light imaging. Structured-light scanning currently has several medical applications due to its speed, accuracy, and robust 3D surface reconstruction, and has been investigated in planning bedside subdural evacuation port system placement. In vitro performance of Bullseye EVD was demonstrated through testing on 3 cadaveric specimens to localize EVD placement on both sides of each of the heads (N=6 trials in total). The success of this in vitro work motivated further development of the technology including clinical evaluation for EVD.

Reducing EVD malpositioning and associated complications is a priority for neurosurgeons, however costly and cumbersome navigation solutions have had limited uptake in this urgent procedure that is often conducted at the bedside. Bullseye EVD represents a portable, safe, low-cost technology that can identify catheter positioning on existing preprocedural CT imaging. The proposed work, including integration into the existing clinical workflow, evaluation of in vivo accuracy and automation to enable rapid feedback during EVD placement, is critical to translating this technology from the bench to the bedside.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • ≥18 years of age
  • Scheduled to undergo placement of an EVD
  • Located in B5 ICU or CRCU
  • Existing pre-procedural head CT imaging

排除标准

  • Set up time poses a safety risk (Clinical discretion)

结局指标

主要结局

Accuracy of the structured light computer vision system

时间窗: Data analysis to start immediately post procedure.

The primary study outcome will be the accuracy of the structured light computer vision system. This will be quantified as the difference between predicted and actual position of the EVD catheter measured as a combined analysis of version error (degrees), inclination error (degrees), and offset error (mm).

次要结局

  • Procedural time for Fiducial placement and optical imaging(Time measured during procedure)
  • Workflow integration(Immediately after procedure)
  • User feedback(Immediately after procedure)

研究者

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

Cari Whyne

Senior scientist, PhD,FIOR

Sunnybrook Health Sciences Centre

研究点 (1)

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