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

This study has been withdrawn prior to enrollment.

(Measurement device not performing to standard in study environment)

Sponsor:

Information provided by (Responsible Party):

Robert Greenberg, MD, Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT01624558

First received: June 11, 2012

Last updated: September 9, 2014

Last verified: September 2014

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:

Genetics Home Reference related topics: malignant hyperthermia

MedlinePlus related topics: Anesthesia Fever

Genetic and Rare Diseases Information Center resources: Malignant Hyperthermia Malignant Hyperthermia Susceptibility Type 6

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.


Enrollment:	0
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

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01624558

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:	September 9, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:


malignant hyperthermia

Additional relevant MeSH terms:


Malignant Hyperthermia Intraoperative Complications Pathologic Processes Postoperative Complications Anesthetics	Central Nervous System Agents Central Nervous System Depressants Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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