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Withdrawn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
About this trial
This is an interventional treatment trial for Malignant Hyperthermia focused on measuring malignant hyperthermia
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
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
NCT ID
NCT01624558
First Posted
June 11, 2012
Last Updated
September 9, 2014
Sponsor
Johns Hopkins University
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Withdrawn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
Learn more about this trial
Effectiveness of Carbon Filters to Reduce the Anesthetic Gas Concentration in an Anesthetized Patient
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