NCT00814424Unknown不适用
Quantitive And Qualitive Assessment Of The Oxygen Delivery And EtCO2 Sampling With The Smart Bite Block Mark III During An Upper Endoscopic Procedure Under Sedation
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- EtCO2 measurement on the investigational device is equivalent to measurement on the control device
研究概览
简要总结
The study hypothesis is that a modified smart bite block system can deliver up to 10 liters/minute of supplemental oxygen orally with the CO2 monitoring performance substantially equivalent to the currently marketed smart bite block that delivers oxygen up to 5 liters/minute
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For the Adults Bite Bloc:Adults >18 years old and able to understand and give consent per the Ethics committee requirements,or younger patients requiring an Adult size Bite Bloc in the opinion of the PI for whom the legal guardians consented for the participation of the trial.
- •Patients consented or which their legal guardians consented for the participation of this trial.
- •Clinical need to use a Bite Bloc to maintain an open mouth and protect the endoscope.
- •Pediatric patients:patients with small mouth that the PI thinks require a Pediatric Bite Bloc (36 French),which their legal guardians consented for the participation of this trial.
排除标准
- •Patients who are pregnant.
- •Patients who in the opinion of the investigator should not participate.
- •For Pediatric Bite Bloc:patients who need an Adult Bite Bloc to the investigators opinion or above the age of
- •Patients receiving oral or intravenous anticoagulants other than Aspirin or Plavix.
结局指标
主要结局
EtCO2 measurement on the investigational device is equivalent to measurement on the control device
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (2)
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