跳至主要内容
临床试验/NCT05964439
NCT05964439招募中不适用

HoloUS: Augmented Reality Visualization of Live Ultrasound Images Using HoloLens for Ultrasound-guided Procedures

Children's National Research Institute2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年3月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
44
试验地点
2
主要终点
Task completion time

研究概览

简要总结

Many medical procedures are done with the aid of ultrasound imaging, but they remain difficult to learn and perform. This study will use augmented reality technology for making these procedures potentially more intuitive, easier, more precise, and safer.

详细描述

Minimally invasive ultrasound-guided procedures are a mainstay of modern medicine and the number of such procedures continues to grow. Safe, efficient, and precise execution of these procedures requires a clear visualization of the target anatomy and the interventional device (e.g., a needle). While sustained advances in ultrasound technology have led to greatly enhanced visualization of the anatomy and the needle with high image quality, hand-eye coordination of the practitioner continues to be a challenge. In order to properly position the interventional device, the practitioner must alternate their attention between observing the patient, advancing the needle, and viewing the ultrasound image on a separate screen. This study's long-term goal is to develop an advanced visualization platform for ultrasound-guided procedures to overcome this challenge by greatly simplifying hand-eye coordination. The proposed platform will be developed using the latest advances in the augmented reality (AR) technology. Through wearable, see-through AR glasses, the platform will create a virtual display placed in the practitioner's field of view to show live ultrasound images, registered with the transducer and the patient, in the form of a hologram. The investigative team hypothesizes that such visualization will reduce the time of procedure by 20%. This study is aimed providing the practitioner a more intuitive and efficient platform to perform ultrasound-guided procedures and demonstrating improved efficiency through user studies.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Employees of the institution over 18 years.
  • Volunteers participants who provide oral consent.
  • For expert group, participants who have been trained to perform and are comfortable with point-of-care ultrasound procedures (e.g., residents, fellows, attendings, vascular access PAs/NPs).

排除标准

  • Any previous experience or training using the current version of the HoloUS app on the HoloLens.

结局指标

主要结局

Task completion time

时间窗: The total time from when the needle first punctured the surface of the phantom to when fluid was successfully aspirated into the syringe, or 10 minutes, whichever occurred first

This outcome measure examines if the use of augmented reality leads to faster procedure.

次要结局

  • Number of head adjustments(From when the needle first punctured the surface of the phantom to when fluid was successfully aspirated into the syringe, or 10 minutes, whichever occurred first.)
  • Number of attempts(From when the needle first punctured the surface of the phantom to when fluid was successfully aspirated into the syringe, or 10 minutes, whichever occurred first.)

研究者

发起方
Children's National Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (2)

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