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

NCT01624558 | Withdrawn

• 1 other identifier: NA_00049358
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malignant Hyperthermia

Keywords

malignant hyperthermia

Outcome Measures

Primary Outcomes (1)

• 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.

  every two minutes after filter applied until concentration is <5ppm or 30 minutes

Study Arms (2)

Treatment (filter in circuit)

EXPERIMENTAL

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

Device: In-line Carbon filter (Vapor-Clean)

No Intervention Control

NO INTERVENTION

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

Interventions

In-line Carbon filter (Vapor-Clean) DEVICE

Carbon filter placed in anesthesia breathing circuit.

Also known as: Vapor-Clean Brand Carbon Filter (Dynasthetics, LLC)

Treatment (filter in circuit)

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• healthy ASA PS I or II children 2 years to 16 years old
• having general anesthesia for approximately 1 hour or more

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

MeSH Terms

Conditions

Malignant Hyperthermia

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Hyperthermia; Body Temperature Changes; Signs and Symptoms

Study Officials

• Robert S Greenberg, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 20, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 11, 2014

Record last verified: 2014-09