Clinical Evaluation of the Origin Intubation System
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Overall intubation duration
研究概览
简要总结
There are currently two options that are utilized are artificial airways in the operating room as well in emergency medicine: the endotracheal tube and the supraglottic airway. However, with these devices, healthcare professionals often experience difficulty and/or failure in utilizing these devices during their first-pass at intubation. Additionally, military medics often forego intubation in favor of basic life support during prolonged resuscitation. This study aims to test a device, one that has been tested in over 100 cadavers, to determine if it is a viable and safer/more successful option for intubation.
详细描述
While previous attempts to address the challenge of airway management involve improved visualization tools (still requiring advanced anatomical knowledge), the focus of this clinical study is to evaluate the performance of the Origin Intubation System, which leverages self-deploying geometry to guide intubation. The enabling technology is vine-inspired tip-growth, in which a soft tube extends from its tip into potentially complex shapes, driven only by a low internal air pressure. This paradigm enables a novel device design that aids in intubation through semi-self-navigation, which is resilient to difficult visualization or user skill, is significantly less traumatic compared to existing methods; and fast (because it does not require the user to identify and navigate the internal anatomy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female subjects 18 years of age or older and less than
- •English or Spanish Speaking.
- •Undergoing elective surgery requiring endotracheal intubation.
- •Use of general anesthesia.
排除标准
- •Patients with high aspiration risk.
- •Inability to provide informed consent in English or Spanish
- •Patients for whom an awake intubation is indicated and planned.
- •Patients with a history of head and neck radiation.
- •Pregnant patients.
- •Patients with BMI >35
- •ASA 4 or higher
- •Patients who the investigator deems ineligible at the investigator's discretion.
- •Planned post-operative intubation.
- •Current incarceration.
研究组 & 干预措施
Use of the Origin Intubation System
The Origin Intubation System will be utilized on participants undergoing general anesthesia for surgery.
干预措施: Origin Intubation System (Device)
结局指标
主要结局
Overall intubation duration
时间窗: Day of surgery.
The time needed for intubation.
次要结局
- Adverse events(From enrollment to follow-up period.)
- User assessment of intubation(Day of surgery.)
- Patient assessment of intubation(Day of surgery.)
- Patient airway characteristics(Day of surgery.)
- First-pass intubation success(Day of surgery.)
- Overall intubation success(Day of surgery.)
研究者
Amit Raj Saxena
Principal Investigator
Stanford University