Comparison of an On-Demand Oxygen Delivery System to Continuous Flow Supplemental Oxygen in the Operating/Procedure Room
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- End-tidal Oxygen
研究概览
简要总结
The main goal of this study is to determine if supplemental oxygen given only when the patient is inspiring (demand delivery) is more effective than constant-flow oxygen given during all phases of the breath regardless if the patient is breathing it in. A previous study in volunteers (NCT02886312) showed that the oxygen saturation in the blood and the concentration of oxygen breathed out from the lungs (end-tidal oxygen) was higher when given in demand (inhalation only) mode. A secondary goal is to determine in patients, whether turning oxygen delivery off during expiration improves the accuracy of end-tidal CO2 (Carbon Dioxide) monitoring. This was found to be the case in the previous volunteer study.
The investigators want to determine if these improvements are also observable in relatively healthy patients undergoing procedural sedation and analgesia. The efficacy of the demand mode will be determined by measuring the resulting difference in oxygen saturation and end-tidal oxygen levels. The investigators will alternate between traditional oxygen delivery (continuous flow) and demand delivery (flow only during inhalation) for two minutes in each mode after which oxygen saturation and end-tidal oxygen will be measured. End-tidal CO2 measurement will be compared with those during the brief time when O2 flow is stopped.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •ASA class I-III
排除标准
- •Procedures scheduled for a lime less than 20 minutes
- •Age < 18 years
- •Baseline SpO2 (arterial oxygen saturation as measured by pulse oximetry) < 93% on room air
- •ARDS (Acute respiratory distress syndrome), lung disease, cardiovascular disease
- •ASA class IV or above
- •Pregnant women.
结局指标
主要结局
End-tidal Oxygen
时间窗: measured every 140 seconds minutes throughout the surgical procedure
Did the novel system increase end-tidal oxygen?
Oxygen Saturation
时间窗: measured continuously with every heart beat (i.e., approx. every 500-2000msec) throughout the surgical procedure
Did the novel system increase oxygen saturation?
End-tidal Carbon Dioxide
时间窗: measured every 140 seconds minutes throughout the surgical procedure
Was end-tidal carbon dioxide measured more accurately using the novel system?
次要结局
未报告次要终点
