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

This study is not yet open for participant recruitment.
Verified June 2012 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Robert Greenberg, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01624558
First received: June 11, 2012
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention
Malignant Hyperthermia
 Device: In-line Carbon filter (Vapor-Clean)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effectiveness of Carbon Filters to Reduce the Anesthetic Gas Concentration in an Anesthetized Patient

Resource links provided by NLM:

MedlinePlus related topics: Fever Gas
U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Time to reduce Concentration of Volatile Anesthetic to <5ppm [ Time Frame: every two minutes after filter applied until concentration is <5ppm or 30 minutes ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 12
Study Start Date: July 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

see above.

  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624558

Contacts
Contact: Robert S Greenberg, MD 410-955-2901 rgreenbe@jhmi.edu
Contact: Tae W Kim, MD 410-955-6412 tkim52@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Not yet recruiting
Baltimore, Maryland, United States, 21287
Sub-Investigator: Tae W Kim, MD            
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Robert S Greenberg, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Robert Greenberg, MD, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01624558     History of Changes
Other Study ID Numbers: NA_00049358
Study First Received: June 11, 2012
Last Updated: June 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
malignant hyperthermia

Additional relevant MeSH terms:
Fever
Malignant Hyperthermia
Body Temperature Changes
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Anesthetics
 Anesthetics, Inhalation
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, General

ClinicalTrials.gov processed this record on May 19, 2013