Airway Data Collection With the Entarik Feeding Tube System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Percentage of accurate airway verifications by the Entarik feeding tube system
研究概览
简要总结
The purpose of this study is to evaluate the airway detection performance of the Entarik Feeding Tube System, and to collect data when the Entarik Feeding Tube is in the Airway for device development.
详细描述
The study is a prospective, single center, non-blinded, single arm study. Subjects who are scheduled to undergo an elective bronchoscopy procedure will have an Entarik Feeding Tube placed into the airway through an endotracheal tube under direct visualization while temperature and impedance data are collected by the Entarik monitor. Other data will be passively simultaneously collected through the Feeding Tube.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years old.
- •Able to provide informed consent.
- •Adults scheduled to undergo a bronchoscopy procedure who will be intubated as part of the standard of care.
排除标准
- •Known major upper airway malformation.
- •Presence of clinically significant respiratory infection.
- •Known bleeding disorder.
- •Currently pregnant.
- •Current basilar skull fracture.
- •Known sensitivities or allergies to the feeding tube components.
- •Deemed unsuitable for enrollment in study by the investigator based on subject's history (e.g., active anticoagulation therapy) or physical examination.
结局指标
主要结局
Percentage of accurate airway verifications by the Entarik feeding tube system
时间窗: During the airway placement procedure
Percentage of accurate verifications of airway placement of the tip of the Entarik feeding tube at the Safety Check Depth.
Incidence of Adverse Events
时间窗: During the airway placement procedure
Incidence of adverse events: (a) related to placement and (b) throughout the duration of the presence of the feeding tube within the subject.
次要结局
未报告次要终点