Neuromuscular BlockadeNCT02912039
Electromyographic Assessment of the TetraGraph in Normal Volunteers
An observational study of Neuromuscular Blockade, run by Mayo Clinic at 1 site in United States.
Trial summary
There is an urgent need for an easy-to-use and accurate quantitative neuromuscular monitor in the clinical setting. The aim of this clinical investigation is to examine a prototype of a quantitative monitoring instrument that will meet most, if not all, of the clinical requirements. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- TetraGraph and TOF Watch
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Mar 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population for this study is normal, healthy, unpremedicated human volunteers.
Who may be able to join
- Age 18 years or older
- Volunteer meets the American Society of Anesthesiology (ASA) physical status I-III criteria
- Volunteer has provided verbal informed consent
Who cannot join
- Presence of an underlying neuromuscular disease
- Use of medications known to interfere with neuromuscular transmission
- Volunteer has open sores/rashes at the locations needed for electrode application
- Volunteer does not tolerate a trial electrical stimulation comfortably.
Trial locations and contacts
1 site in 1 country.
About this study
There is an urgent need for an easy-to-use and accurate quantitative neuromuscular monitor in the clinical setting. The aim of this clinical investigation is to examine a prototype of a quantitative monitoring instrument that will meet most, if not all, of the clinical requirements.
- Conditions
- Neuromuscular Blockade
- Being tested
- TetraGraph, TOF Watch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetraGraphDevice
A sequence of 3 sets of Train of four (TOF) stimuli delivered (every 20 sec) at the pre-determined current amplitude (for instance, 40 mA, then 30 mA, then 50 mA, then 20 mA).
TOF WatchDevice
A sequence of 3 sets of TOF stimuli delivered (every 20 sec) at the pre-determined current amplitude (for instance, 40 mA, then 30 mA, then 50 mA, then 20 mA).
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of train of four measurements between TOF Watch and TetraGraph
The primary endpoint will be an analysis of the agreement between the TOF-Watch (the current gold standard) and TetraGraphTM devices during neuromuscular monitoring. Data Acceleromyography (AMG) and Electromyography (EMG) will be compared between the two devices during testing of single twitch (ST) and train of four (TOF) patterns at varying current amplitudes, from threshold amplitude (the lowest current amplitude that is able to generate a muscle response), to supramaximal current amplitude (the amplitude that elicits maximal muscle response). Bias and limits of agreement will be calculated for each stimulation pattern (ST and TOF) at currents between submaximal and supramaximal amplitude. Measured responses obtained with the two technologies (AMG and EMG) will be compared.
Measured: During stimulation
Secondary outcomes (7)
Noise level
Acceptable levels of electrical noise when no stimulus is being applied (random noise, power-line noise, and background EMG recorded in a relaxed volunteer with low recording electrode impedance should be 0.2 mV RMS or less).
Measured: During stimulation
Stimulus artifact
That the stimulus artifact will not obscure the EMG response when a stimulus is applied.
Measured: During stimulation
Appearance EMG response
Appearance of an EMG response at threshold stimulation levels, enough to just barely elicit a visible twitch response and elicit measurable acceleration on the TOF-Watch.
Measured: During stimulation
EMG amplitude
Increase in the amplitude of the EMG response, with constant response latency, corresponding to the increase in the AMG response as stimulus strength (current) is increased.
Measured: During stimulation
Maximal EMG amplitude
The observation of a maximal EMG amplitude, corresponding to the maximal AMG response, at maximal and supramaximal (up to maximal+10%, but below 70 mA) stimulus levels.
Measured: During stimulation
Consistency in amplitude
Consistency in the amplitude of the AMG and EMG response amplitudes, with measured variations less than 10%, on repeated 1 Hz stimulation when the stimulus current is held constant between threshold and supramaximal intensity.
Consistency of the AMG and EMG response amplitudes in repeated (ST and TOF) stimulus protocols (in which variation should be less than 10%).
Consistency of EMG response characteristics and association with AMG responses independent of patient age, gender, or weight (despite different stimulus amplitudes being required to elicit submaximal and supramaximal responses).
Consistency of EMG response characteristics and association with AMG responses independent of whether the right or left arm is being stimulated.
Measured: During stimulation
Discomfort level
Establish the discomfort associated with nerve stimulation (from submaximal to supramaximal current amplitudes) in awake, unpremedicated human volunteers. Assessment will be made using an 11-point visual analog score (VAS) scale, anchored with 0 = no distress and 10 = worst distress ever experienced
Measured: During stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Ross Renew, M.D., Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912039
- Sponsor's protocol ID
- 16-005022
- Status last verified
- Jul 2018
- First submitted
- 21 Sep 2016
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromyographic Assessment of the TetraGraph in Normal Volunteers
- ClinicalTrials.gov ID
- NCT02912039
- Acronym / sponsor ID
- 16-005022
- Conditions
- Neuromuscular Blockade
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 23 Sep 2016 (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.
There is an urgent need for an easy-to-use and accurate quantitative neuromuscular monitor in the clinical setting. The aim of this clinical investigation is to examine a prototype of a quantitative monitoring instrument that will meet most, if not all, of the clinical requirements.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population for this study is normal, healthy, unpremedicated human volunteers.
Key inclusion criteria (3 listed)
- Age 18 years or older
- Volunteer meets the American Society of Anesthesiology (ASA) physical status I-III criteria
- Volunteer has provided verbal informed consent
Key exclusion criteria (4 listed)
- Presence of an underlying neuromuscular disease
- Use of medications known to interfere with neuromuscular transmission
- Volunteer has open sores/rashes at the locations needed for electrode application
- Volunteer does not tolerate a trial electrical stimulation comfortably.
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 |
|---|---|---|
| TetraGraphA sequence of 3 sets of Train of four (TOF) stimuli delivered (every 20 sec) at the pre-determined current amplitude (for instance, 40 mA, then 30 mA, then 50 mA, then 20 mA). | Device | – |
| TOF WatchA sequence of 3 sets of TOF stimuli delivered (every 20 sec) at the pre-determined current amplitude (for instance, 40 mA, then 30 mA, then 50 mA, then 20 mA). | Device | – |
Primary outcome
Comparison of train of four measurements between TOF Watch and TetraGraph
Time frame: During stimulation
The primary endpoint will be an analysis of the agreement between the TOF-Watch (the current gold standard) and TetraGraphTM devices during neuromuscular monitoring. Data Acceleromyography (AMG) and Electromyography (EMG) will be compared between the two devices during testing of single twitch (ST) and train of four (TOF) patterns at varying current amplitudes, from threshold amplitude (the lowest current amplitude that is able to generate a muscle response), to supramaximal current amplitude (the amplitude that elicits maximal muscle response). Bias and limits of agreement will be calculated for each stimulation pattern (ST and TOF) at currents between submaximal and supramaximal amplitude. Measured responses obtained with the two technologies (AMG and EMG) will be compared.
7 secondary outcomes
Noise level
Time frame: During stimulation
Stimulus artifact
Time frame: During stimulation
Appearance EMG response
Time frame: During stimulation
EMG amplitude
Time frame: During stimulation
Maximal EMG amplitude
Time frame: During stimulation
Consistency in amplitude
Time frame: During stimulation
Discomfort level
Time frame: During stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Blockade, run by Mayo Clinic at 1 site in United States.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of train of four measurements between TOF Watch and TetraGraph (time frame: During stimulation). 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 17 May 2023.