An interventional study of In-line Carbon filter (Vapor-Clean) in Malignant Hyperthermia, sponsored by Johns Hopkins University. Withdrawn. Open to participants aged 2 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-11.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
see above.
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Exclusion Criteria:
After baseline use of volatile anesthetic, this group will have carbon filter placed in-line.
Device: In-line Carbon filter (Vapor-Clean)
After baseline use of volatile anesthetic, this group will NOT have carbon filter placed in-line.
Carbon filter placed in anesthesia breathing circuit.
Also known as: Vapor-Clean Brand Carbon Filter (Dynasthetics, LLC)
Time to reduce Concentration of Volatile Anesthetic to <5ppm
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.
Time frame: every two minutes after filter applied until concentration is <5ppm or 30 minutes
No study locations are listed for this record.
This study is withdrawn, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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