Electronic Nose Identification of Fasting and Non-fasting Breath Profiles
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 879
- 试验地点
- 1
- 主要终点
- Effectiveness of the Aeonose in Distinguishing a Fasting Versus Non-fasting Breath Profile
研究概览
简要总结
The investigators will study a noninvasive no risk process by which the investigators can quickly screen and assess for fasting and non-fasting states in individuals scheduled for routine endoscopy.
详细描述
The investigators will study a noninvasive no risk process by which we can quickly screen and assess for fasting and non-fasting states in individuals scheduled for routine endoscopy. In non-fasting individuals, the risk of a sedation related complication such as aspiration increases and often the procedure must be aborted and repeated on another day following more prolonged fasting and medication administration. This adds to increased cost and delay to patient care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- 否
入选标准
- •Inclusion Criteria:
- •Adult (18+) patient undergoing scheduled elective outpatient upper endoscopy
- •Willing and able to consent to research protocol
- •Fasting as required per routine instruction for upper endoscopy
- •Able to breath for approximately 10 minutes pre and post procedure into the Aeonose device with a nose-plug on
- •Able to consume standard refreshments post procedure during recovery per routine endoscopic area policy
排除标准
- •Non-fasting per protocol, or known to have had food or drink outside of routine protocol
- •< 18 years of age
- •Unable or unwilling to consent to research protocol
- •Inability to tolerate Aeonose breathing (such as those with claustrophobia, anxiety, nasal trauma, etc.)
- •Unable to consume refreshment post procedurally
- •Unable to repeat Aeonose measurement post-procedurally due to tolerance or medical indication (such as instructed to remain fasting)
研究组 & 干预措施
Breath Analysis
Individuals consenting to participation of this study will be asked to provide a breath analysis using the Aeonose. Following their scheduled standard of care endoscopic procedure the patient will repeat the breath analysis.
干预措施: a breath analysis using the Aeonose (Other)
Breath Analysis
Individuals consenting to participation of this study will be asked to provide a breath analysis using the Aeonose. Following their scheduled standard of care endoscopic procedure the patient will repeat the breath analysis.
干预措施: Aeonose (Device)
结局指标
主要结局
Effectiveness of the Aeonose in Distinguishing a Fasting Versus Non-fasting Breath Profile
时间窗: breath analysis obtained (approximately 10 minutes procedure)
Exhaled Volatile Organic Compounds (VOCs) were collected by subject's breathing into a non-invasive breath analyzer (Aeonose) for 5 minutes by which through pattern recognition electronic changes can be identified in exhaled volatile organic compounds interfacing with an electronic sensor that creates an electronic signature, or smell-print that distinguishes the fasting and non-fasting states. The effectiveness of the Aeonose in distinguishing subjects in a fasting versus non-fasting state is represented by the device's sensitivity and specificity (ability to positively identify subjects who are in a fasting state versus non-fasting state).
次要结局
未报告次要终点
研究者
Cadman Leggett
Principal Investigator
Mayo Clinic