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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This study has been withdrawn prior to enrollment.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:
Johns Hopkins University
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
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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 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 |
Resource links provided by NLM:
Further study details as provided by Robert Greenberg, MD, 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 ]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 (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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01624558
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
| 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 |
Keywords provided by Robert Greenberg, MD, Johns Hopkins University:
|
malignant hyperthermia |
Additional relevant MeSH terms:
|
Fever Malignant Hyperthermia Body Temperature Changes Signs and Symptoms Intraoperative Complications Pathologic Processes |
Postoperative Complications Anesthetics Anesthetics, Inhalation Central Nervous System Depressants Physiological Effects of Drugs Anesthetics, General |
ClinicalTrials.gov processed this record on August 17, 2017