跳至主要内容
临床试验/NCT02962570
NCT02962570进行中(未招募)不适用

Comparison of an On-Demand Oxygen Delivery System to Continuous Flow Supplemental Oxygen in the Operating/Procedure Room

University of Utah2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年11月最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kai Kuck

Ph.D.

University of Utah

研究点 (2)

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