跳至主要内容
临床试验/NCT01624558
NCT01624558撤回不适用

Effectiveness of Carbon Filters to Reduce the Anesthetic Gas Concentration in an Anesthetized Patient

Johns Hopkins University0 个研究点开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Time to reduce Concentration of Volatile Anesthetic to <5ppm

研究概览

简要总结

Malignant hyperthermia is a potentially fatal inherited disorder triggered by exposure to volatile anesthetic gases, most commonly recognized in children during anesthesia. Carbon filters have been used to scavenge various gases. A new carbon filter (Vapor Clean, Dynasthetics, LLC, Salt Lake City, Utah) with a 510(k) clearance specifically for scavenging anesthetic gases is being marketed, though the filter itself has never been studied in vivo. Bench studies conducted by the manufacturer of the product demonstrate it is extremely effective in reducing the volatile gas output from an anesthesia machine within 2 minutes. This pilot study will measure the effect on volatile gas concentration in non-malignant hyperthermia susceptible patients. Twelve (12) patients will undergo standard anesthetic induction using inhalational anesthetic (Sevoflurane®) and maintained on 3% for 30 minutes to attain steady state concentrations.1 At that time, a total intravenous anesthetic technique will be started and maintained throughout the case. Simultaneously a Vapor Clean filterset will be placed in the breathing circuit (inspiratory and expiratory limbs). Volatile gas concentration will be measured and recorded. This research will determine the feasibility of using this carbon filter to quickly reduce the breathing circuit gas concentration of volatile anesthetic in the clinical setting. This is fundamental in establishing this as a key life saving measure in eliminating the stimulus in a malignant hyperthermia event.

详细描述

see above.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
2 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • healthy ASA PS I or II children 2 years to 16 years old
  • having general anesthesia for approximately 1 hour or more

排除标准

  • malignant hyperthermia susceptible patients (personal or family history)
  • patients with known neuromuscular disorders at high risk of malignant hyperthermia (e.g., muscular dystrophy)
  • egg or soy allergy
  • patient or parent refusal
  • pregnant patients

结局指标

主要结局

Time to reduce Concentration of Volatile Anesthetic to <5ppm

时间窗: every two minutes after filter applied until concentration is <5ppm or 30 minutes

At regular intervals (2 minutes) after application of the filters, the concentration of the volatile anesthetic will be measured. Primary outcome value will be the time to reduce breathing circuit volatile anesthetic concentration to \<5ppm. If at 30 min the concentration is not \<5ppm, then collection will be stopped.

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

Robert Greenberg, MD

Associate Professor

Johns Hopkins University

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