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

Primary Purpose

Malignant Hyperthermia

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
In-line Carbon filter (Vapor-Clean)
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Hyperthermia focused on measuring malignant hyperthermia

Eligibility Criteria

2 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Treatment (filter in circuit)

    No Intervention Control

    Arm Description

    After baseline use of volatile anesthetic, this group will have carbon filter placed in-line.

    After baseline use of volatile anesthetic, this group will NOT have carbon filter placed in-line.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 11, 2012
    Last Updated
    September 9, 2014
    Sponsor
    Johns Hopkins University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01624558
    Brief Title
    Effectiveness of Carbon Filters to Reduce the Anesthetic Gas Concentration in an Anesthetized Patient
    Official Title
    Effectiveness of Carbon Filters to Reduce the Anesthetic Gas Concentration in an Anesthetized Patient
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Measurement device not performing to standard in study environment
    Study Start Date
    July 2012 (undefined)
    Primary Completion Date
    June 2013 (Anticipated)
    Study Completion Date
    June 2013 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Johns Hopkins University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    see above.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malignant Hyperthermia
    Keywords
    malignant hyperthermia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment (filter in circuit)
    Arm Type
    Experimental
    Arm Description
    After baseline use of volatile anesthetic, this group will have carbon filter placed in-line.
    Arm Title
    No Intervention Control
    Arm Type
    No Intervention
    Arm Description
    After baseline use of volatile anesthetic, this group will NOT have carbon filter placed in-line.
    Intervention Type
    Device
    Intervention Name(s)
    In-line Carbon filter (Vapor-Clean)
    Other Intervention Name(s)
    Vapor-Clean Brand Carbon Filter (Dynasthetics, LLC)
    Intervention Description
    Carbon filter placed in anesthesia breathing circuit.
    Primary Outcome Measure Information:
    Title
    Time to reduce Concentration of Volatile Anesthetic to <5ppm
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert S Greenberg, MD
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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