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This study has been withdrawn prior to enrollment.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

June 11, 2012
September 9, 2014
July 2012
June 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01624558 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effectiveness of Carbon Filters to Reduce the Anesthetic Gas Concentration in an Anesthetized Patient
Effectiveness of Carbon Filters to Reduce the Anesthetic Gas Concentration in an Anesthetized Patient

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.

see above.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Malignant Hyperthermia
Device: In-line Carbon filter (Vapor-Clean)
Carbon filter placed in anesthesia breathing circuit.
Other Name: Vapor-Clean Brand Carbon Filter (Dynasthetics, LLC)
  • Experimental: Treatment (filter in circuit)
    After baseline use of volatile anesthetic, this group will have carbon filter placed in-line.
    Intervention: Device: In-line Carbon filter (Vapor-Clean)
  • No Intervention: No Intervention Control
    After baseline use of volatile anesthetic, this group will NOT have carbon filter placed in-line.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
2 Years to 16 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01624558
NA_00049358
No
Robert Greenberg, MD, Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Robert S Greenberg, MD Johns Hopkins University
Johns Hopkins University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP