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临床试验/NCT02195245
NCT02195245已完成不适用

A New and Innovative Method for CO2 Removal in Anesthetic Circuits: Replacing Chemical Granulate

DMF Medical Incorporated2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
End tidal CO2 level

研究概览

简要总结

CO2 removal is a mandatory part of modern anesthesia systems. Current chemical absorbers pose problems as the chemical granulate reacts not only with the CO2 but also the anesthetic drugs, producing organ toxic substances. The proposed CO2 absorber provides a solution to the problem of organ-toxin production in anesthetic circuits.

详细描述

CO2 removal is a mandatory part of modern anesthesia systems. Current chemical absorbers pose problems as the chemical granulate reacts not only with the CO2 but also the anesthetic drugs, producing organ toxic substances. The proposed CO2 absorber provides a solution to the problem of organ-toxin production in anesthetic circuits.

This new absorber can be easily integrated into any anesthesia circuit, and can effectively remove CO2 without reacting with anesthetic drugs, thus eliminating organ-toxic by-products.

It uses advanced membrane technology to separate gas flows within the circuit, separating the expensive anesthetic vapors from the CO2 (the main by-product of metabolism). Anesthetic vapors thus remain in the closed loop circuit, while CO2 is separated and exhausted to the atmosphere, rather than being absorbed through a chemical reaction.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiology Physical Status Class I, II, III (low-medium risk patient)
  • English-speaking patients
  • Scheduled for elective surgery
  • Length of anesthesia ≥ 60 minutes

排除标准

  • American Society of Anesthesiology Physical Status Class IV (high risk patient)
  • Patients schedule for emergency surgery
  • Known respiratory disease, including COPD and severe asthma
  • Have elevated pressure in your brain (intra cranial pressure, ICP)

结局指标

主要结局

End tidal CO2 level

时间窗: Continuous (5min intervals) over duration of anesthesia. No data collection prior or post anesthesia.

After completion of the surgery, the digital respiration records are exported from the hospital database. End tidal CO2 is assessed as either in range \[4.1-5.6\]% or out of range \<4.1% or \>5.6%.

次要结局

未报告次要终点

研究者

发起方
DMF Medical Incorporated
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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