Malignant HyperthermiaNCT01624558
Effectiveness of Carbon Filters to Reduce the Anesthetic Gas Concentration in an Anesthetized Patient
A study testing In-line Carbon filter (Vapor-Clean) in people with Malignant Hyperthermia, run by Johns Hopkins University.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Malignant Hyperthermia
- What is being tested?
- In-line Carbon filter (Vapor-Clean)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy ASA PS I or II children 2 years to 16 years old
- having general anesthesia for approximately 1 hour or more
Who cannot join
- 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
About this study
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.
Read the detailed description
see above.
- Conditions
- Malignant Hyperthermia
- Being tested
- In-line Carbon filter (Vapor-Clean)
- Keywords
- malignant hyperthermia
- Medical subject headings
- Malignant Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-line Carbon filter (Vapor-Clean)Device
Also called Vapor-Clean Brand Carbon Filter (Dynasthetics, LLC)
Carbon filter placed in anesthesia breathing circuit.
| Study group | Role | What they receive |
|---|---|---|
| Treatment (filter in circuit) | Experimental | After baseline use of volatile anesthetic, this group will have carbon filter placed in-line. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: every two minutes after filter applied until concentration is <5ppm or 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Why it stopped: Measurement device not performing to standard in study environment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant HyperthermiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Greenberg, MD, Johns Hopkins University
- Investigators
- Robert S Greenberg, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624558
- Sponsor's protocol ID
- NA_00049358
- Status last verified
- Sep 2014
- First submitted
- 11 Jun 2012
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Carbon Filters to Reduce the Anesthetic Gas Concentration in an Anesthetized Patient
- ClinicalTrials.gov ID
- NCT01624558
- Acronym / sponsor ID
- NA_00049358
- Conditions
- Malignant Hyperthermia
- Keywords
- malignant hyperthermia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Measurement device not performing to standard in study environment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 20 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment (filter in circuit) | Experimental | Device: In-line Carbon filter (Vapor-Clean)After baseline use of volatile anesthetic, this group will have carbon filter placed in-line. |
| No Intervention Control | No intervention | –After baseline use of volatile anesthetic, this group will NOT have carbon filter placed in-line. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- healthy ASA PS I or II children 2 years to 16 years old
- having general anesthesia for approximately 1 hour or more
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-line Carbon filter (Vapor-Clean)Also: Vapor-Clean Brand Carbon Filter (Dynasthetics, LLC)Carbon filter placed in anesthesia breathing circuit. | Device | Treatment (filter in circuit) |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S Greenberg, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing In-line Carbon filter (Vapor-Clean) in people with Malignant Hyperthermia, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2014.