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临床试验/NCT04028284
NCT04028284已完成不适用

Using Augmented Reality to 3D Map Needle Pathways in Real Time to Enhance Neuraxial Anesthesia

Sunnybrook Health Sciences Centre1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2019年1月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
1
主要终点
Procedure Time

研究概览

简要总结

Neuraxial anesthesia has traditionally been a 'blind' technique relying on users' feel and skill, both are subjective, lack complete accuracy and influenced by patient's physique variations that are quite challenging, and lead to patient morbidity, infection, and nerve injury. The ultrasound(US) use allows real-time views of needle position thereby achieving higher success rates, fewer complications, and reduced patient discomfort. While US guidance for neuraxial procedures is popular, it is still relatively uncommon due to technical and anatomical challenges. The study investigators have created an innovative methodology to use with HoloLens, an augmented reality tool, to provide an accurate live road map for the needle path hidden under the patient's skin. This see-through model is an objective alternative to the user's memory for direct visualization of the needle virtual trajectory as it passed through the tissue and towards the 3D printed bone. Also, this model may have a variety uses in anesthesia.

详细描述

US guidance for epidural anesthesia is yet challenging due to anatomical and technical restrictions which are rely on the operator's memory to imitate accurate needle trajectory. To address the problem, the study investigators designed and developed the first model of a live anatomical holographic marking system using Microsoft HoloLens, an augmented reality technology tool, to provide a superimposed US image as an objective alternative to the operator's memory. In this study, the proposed methodology will be used to accurate and ease directing the needle insertion thereby leading to the success of the epidural placement and decrease in procedure time. Based on previously published and data from the SHSC institution, mean thoracic epidural analgesia placement required 10 minutes with a standard deviation of 3 minutes. A reduction in procedure time will reduce patient discomfort, increase block and operating rooms efficiency thereby reducing hospital costs as well as used for anatomically challenging patients.

The investigators hypothesize that using augmented reality through HoloLens will lead to implementation of a newly developed virtual holographic 'see-through' tool for neuraxial anesthetic techniques that will increase needle accuracy and decrease procedure time.

The main question of the study is to assess the accuracy of the developed application. In particular, the study will determine if a holographic marking of the site of needle insertion and optimal angulation will increase needle accuracy and reduce procedure time by increasing first past success when compared to traditional ultrasound land-mark based techniques.

The methodology proposed in this study is truly innovative in medical content, involves a partnership with software and engineering experts. The study will lead to implementation of a new objective tool, validation of which will create an accessible, cost-effective piece of technology that will reduce patient morbidity and increase procedure success rate. This 'state-of-the-art' technology can be used for alternate procedures such as peripheral nerve block in patients that cannot be easily positioned for live US techniques. Also, this study will generate a knowledge-based approach that can be used as a teaching and clinical tool locally at institutions presented with anatomically difficult population (e.g. trauma, obstetric patients) at Sunnybrook Health Sciences Centre and around the world, where resources are at a minimum.

This is a prospective cohort randomized trial. With institutional ethical approval and having obtained both, written informed consent and verbal assent from participants, 84 thoracic epidural events will be assessed. A thoracic spine US 3D Phantom model utilizing open source BodyParts3D library anatomy files constructed by group of software and engineering experts, and accessible for practice to anesthetists. Our 3D Phantom model has similar palpation characteristics to a patient mimicking a standard loss of resistance to saline that occurs on entrance of a needle to the spinal canal cavity. The holographic mapping methodology will be practiced by anesthetists on the Phantom model until they feel comfortable with the system prior the study start. Participants will be recruited from the pre-anesthesia clinic. Only participants who meet inclusion criteria will be approached for participation in this study (Table 1,inclusion/exclusion criteria, study protocol). The anesthetists will be randomized to: Group1, landmark based thoracic epidural technique(control) or, Group 2, HoloLens-assisted thoracic epidural technique(intervention), where the needle will be inserted using instantly created holographic trajectory. SHS centre has a dedicated regional block room and four regional expert anesthetists in the US-guided thoracic epidural technique and are comfortable with the HoloLens. Prior to the study start, anesthetists will practice needle insertion on the phantom model by attempting needle insertion 20Xeach, or until they felt comfortable with the tool, while wearing HoloLens. Other aspects of patient care will follow the standard of care at the centre. Data will be collected by anesthetists and include patients surgical/abdominal pain assessment during epidural procedure and post-operatively, and questionnaire about their experience using the HoloLens.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Device Feasibility
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
是

入选标准

  • •Trained in US-guided epidural technique with fellowship
  • •Performed >100 thoracic US-guided epidural procedures

排除标准

  • •Lack of verbal patient assent after study introduction

研究组 & 干预措施

Group 1

Active Comparator

In Group 1 (control), the staff anesthesiologist will follow the traditional technique for US-guided thoracic epidural insertion. Briefly, the anesthesiologist will use the US to identify and mark the appropriate spot for placement of the thoracic epidural catheter. The US probe is then placed at rest and the anesthesiologist will proceed with thoracic epidural needle insertion following standard techniques.

干预措施: US-guided epidural (Other)

Group 2

Active Comparator

In Group 2 (intervention), the staff anesthesiologist will use the HoloLens tool to assist with the traditional technique as described above for Group 1. In combination with the US, a hologram image of the trajectory towards the epidural space will be generated, thereby mitigating the need to walk off the lamina. The holographic system will mark the appropriate spot for placement of the thoracic epidural catheter. Then, the needle will be inserted following the holographic trajectory overlaid on the patient's back.

干预措施: HoloLens-guided epidural (Device)

结局指标

主要结局

Procedure Time

时间窗: During procedure

The time starting from skin puncture until withdrawal of the Tuohy needle after successful catheter placement.

次要结局

  • Number of Needle Insertions(During procedure)
  • Number of Needle Passes(During procedure)
  • Pain in PACU(In the PACU)
  • Number of Bone Contacts(During procedure)
  • Procedural Pain(During procedure)
  • Number of Participants With Epidural Failure(In the PACU)
  • Complications(During procedure)

研究者

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

Dr. Fahad Alam

Principal Investigator

Sunnybrook Health Sciences Centre

研究点 (1)

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