Holo CTO Proctoring Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Standard Usability Score on a Likert Scale
研究概览
简要总结
Assess Microsoft HoloLens as an interactive communication device in remote proctoring, and enhancement of teamwork in complex CTO procedures
详细描述
Proctoring in medicine is related to better outcomes. Specifically, in CTO PCI systematic proctoring has demonstrated improved success rates, and an increased ability to treat lesions that are more complex. Most likely, proctoring together with operator volume is one of the foundations to the introduction and execution of CTO procedures. Proctoring traditionally involves an expert operator (proctor), visiting the institution, performing the procedure together with the local operator. This involves increased cost, and current travel restrictions makes traditional one-on-one proctoring challenging.
This study aims to evaluate the Microsoft HoloLens as a potential platform in proctoring and effective real time communication between PCI operators located at different geographical locations. The proctor and the local operator interact using a head mounted mixed reality (MR) display, enabling the proctor to see the same image as the operator, from any distanced location.
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
- 否
入选标准
- •Clinical inclusion criteria:
- •Stable angina pectoris, or dyspnoea as an angina equivalent
- •Age ≥18 yrs.
- •Able to provide written informed consent
- •Angiographic inclusion criteria:
- •One or more completely occluded coronary arteries with Thrombolysis In Myocardial Infarction (TIMI) flow
- •An estimated occlusion duration of at least 3 months
- •Absence of Q-wave in ECG leads corresponding to the occluded vessel, or documented viability of the main territory by MRI or echocardiography
- •Procedural inclusion criteria:
- •Clinical indication for CTO PCI regardless of operative technique
排除标准
- •STEMI within 72 hours
- •Cardiogenic shock
- •Active bleeding or coagulopathy
- •Life expectancy < 2 years
- •Relevant allergies (aspirin, clopidrogrel, ticagrelol, contrast compounds)
- •Severe peripheral artery disease
- •Clinical unstable angina
结局指标
主要结局
Standard Usability Score on a Likert Scale
时间窗: Procedure duration( aprox 120 min)
The operators completing the intervention will rate the usability of the system on a Likert scale: 1. The HoloLens was useful in this procedure 2. The HoloLens was not distracting 3. The HoloLens was comfortable to wear 4. The HoloLens camera image has sufficient quality for clinical use (not considering the fluoroscopy screen) 5. Compared to an alternative system with fluoroscopy image plus handsfree voice (telephone), the HoloLens gives additional value during the procedure 6. The current solution with Remote Assist plus parallel fluoroscopy streaming is mature enough for routine use 7. The current solution is stable 8. The current solution is easy to set up prior to the procedure 9. I would like to continue to use the HoloLens in CTO procedures routinely when remote proctoring is needed Agree to Disagree Likert Scale * Strongly Disagree * Disagree * Neither agree nor disagree * Agree * Strongly Agree
次要结局
未报告次要终点