跳至主要内容
临床试验/NCT04210570
NCT04210570Unknown不适用

Decreasing Environmental Impact and Costs of Using Inhalational Anesthetics by Replacing Chemical Absorbers With an Innovative Carbon Dioxide Membrane Filter System - a Prospective, Randomized, Clinical Trial

Western University, Canada1 个研究点 分布在 1 个国家目标入组 510 人开始时间: 2021年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
510
试验地点
1
主要终点
Effectiveness of Memsorb compared to CGA to eliminate CO2

研究概览

简要总结

Efficient inhalational anesthetic delivery requires the use of low-flow air and oxygen to reduce drug waste and minimize workspace contamination and environmental pollution. Currently, excess anesthetic gas is scavenged and removed from the operating room via the hospital ventilation system, where it is released into the atmosphere. CO2 is removed from the anesthesia circuit by the use of CO2 removal systems to prevent re-breathing and potential hypercarbia.

Carbon dioxide is currently removed using chemical granulate absorbers (CGAs), which trap CO2 in the granules that are later disposed of when absorption capacity is reached. They require replacement approximately every other day when used in moderate to high volume surgical centres, placing a costly burden on the healthcare system and environment (landfill).

One of the more concerning downfalls of using CGAs is the potential for the inhalational anesthetics to react with the granules and potentially produce toxic byproducts known as compounds A-E that are nephrotoxic and neurotoxic and require excess amounts of anesthetic gas to dilute.

This excess use of anesthetics gases places a financial burden on the healthcare system and has a detrimental impact on the environment. The vast majority of the gases used are eventually released into the environment with little to no degradation where they accumulate in the troposphere and act as greenhouse gases.

DMF Medical has created Memsorb, a new CO2 filtration membrane. Memsorb can remove CO2 from the anesthesia circuit without the use of CGAs, thereby eliminating the potential for toxic byproducts and allowing for significantly lower air and oxygen flow to be used, resulting in less use of inhalational anesthetics. Memsorb uses a polymeric membrane (similar to the ones used in oxygenators for cardiac surgery) that selectively allows CO2 to leave the rebreathing system, while maintaining the inhalational anesthetic in the circuit.

The lifespan of Memsorb is at least 12 months, resulting in less particulate waste and a decreased cost to the healthcare system.

We wish to evaluate the ability and efficacy of Memsorb in removing CO2 from the anesthesia circuit while maintaining physiologic minute volume ventilation, as compared to the traditional CGAs in a variety of surgical procedures, patient populations, and anesthesia gas flows.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Care Provider)

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 I - III
  • Elective surgical procedure
  • Laparoscopic surgery for study aim III

排除标准

  • ASA > IV
  • Emergency surgery
  • Severe respiratory disease (eg Asthma)
  • Raised intracranial pressure
  • Regional anesthesia
  • Absence of arterial line for study aim III
  • Self-reported pregnancy

研究组 & 干预措施

Memsorb GA

Experimental

Memsorb Filter will be used during general anesthesia (GA), fresh gas flow and ventilator settings are not modified

干预措施: Memsorb (Device)

CGA GA

Active Comparator

Chemical CO2 absorber (CGA) will be used during general anesthesia (GA), fresh gas flow and ventilator settings are not modified

干预措施: Chemical granulate absorber (Drug)

Memsorb low-flow

Experimental

Memsorb Filter will be used during low flow general anesthesia (GA)

干预措施: Memsorb (Device)

CGA low flow

Experimental

Chemical CO2 absorber (CGA) will be used during low flow general anesthesia (GA)

干预措施: Chemical granulate absorber (Drug)

Memsorb laparoscopic surgery

Experimental

Memsorb Filter will be used during general anesthesia for laparoscopic surgery

干预措施: Memsorb (Device)

CGA laparoscopic surgery

Experimental

Chemical CO2 absorber (CGA) will be used during laparoscopic surgery

干预措施: Chemical granulate absorber (Drug)

结局指标

主要结局

Effectiveness of Memsorb compared to CGA to eliminate CO2

时间窗: Duration of general anesthesia (up to 12 hours)

etCO2 (mmHg) and tidal volumes (ml) will be measured with the two systems in GE / Dates Ohmeda anesthesia machines

Impact of Memsorb, using minimal flow anesthesia (≤ 0.50 L/min), on the amount of inhalational anesthetic (ml) used, compared to standard practice

时间窗: Duration of general anesthesia (up to 12 hours)

Usage of Desflurane in ml will be measured during minimal flow (≤ 0.5 L/min) anesthesia, compared to traditional higher gas flow (\> 2 L/min).

Effectiveness of using Memsorb during ventilation for removal of CO2 in laparoscopic surgeries resulting in high CO2 exposure, compared to CGAs

时间窗: Duration of general anesthesia (up to 12 hours)

etCO2 (mmHg), paCO2 (mmHg) and tidal volumes (ml) needed remove CO2 during laparoscopic surgery, resulting in higher CO2 exposure.

次要结局

  • Amount of inhaled anesthetics used(Duration of general anesthesia (up to 12 hours))
  • Duration of anesthesia(Duration of general anesthesia (up to 12 hours))
  • Water build up in anesthesia circuit(Duration of general anesthesia (up to 12 hours))
  • Freshgas flow during general anesthesia(Duration of general anesthesia (up to 12 hours))
  • Number of CGAs used during the study period(Duration of general anesthesia (up to 12 hours))
  • Minute volume ventilation(Duration of general anesthesia (up to 12 hours))

研究者

发起方
Western University, Canada
申办方类型
Other
责任方
Sponsor

研究点 (1)

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