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

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ClinicalTrials.gov Identifier: NCT01624558
Recruitment Status : Withdrawn (Measurement device not performing to standard in study environment)
First Posted : June 20, 2012
Last Update Posted : September 11, 2014
Sponsor:
Information provided by (Responsible Party):
Robert Greenberg, MD, Johns Hopkins University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malignant Hyperthermia Device: In-line Carbon filter (Vapor-Clean) Not Applicable

Detailed Description:
see above.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effectiveness of Carbon Filters to Reduce the Anesthetic Gas Concentration in an Anesthetized Patient
Study Start Date : July 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (filter in circuit)
After baseline use of volatile anesthetic, this group will have carbon filter placed in-line.
 Device: In-line Carbon filter (Vapor-Clean)
Carbon filter placed in anesthesia breathing circuit.
Other Name: Vapor-Clean Brand Carbon Filter (Dynasthetics, LLC)
No Intervention: No Intervention Control
After baseline use of volatile anesthetic, this group will NOT have carbon filter placed in-line.


Outcome Measures
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Primary Outcome Measures :
  1. Time to reduce Concentration of Volatile Anesthetic to <5ppm [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01624558


Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Robert S Greenberg, MD Johns Hopkins University
More Information
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Responsible Party: Robert Greenberg, MD, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01624558    
Other Study ID Numbers: NA_00049358
First Posted: June 20, 2012    Key Record Dates
Last Update Posted: September 11, 2014
Last Verified: September 2014
Keywords provided by Robert Greenberg, MD, Johns Hopkins University:
malignant hyperthermia
Additional relevant MeSH terms:
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Hyperthermia
Fever
Malignant Hyperthermia
Body Temperature Changes
Heat Stress Disorders
 Wounds and Injuries
Intraoperative Complications
Pathologic Processes
Postoperative Complications