Skip to main content
OpenTrials
Completed

NCT Number: NCT02912039

Electromyographic Assessment of the TetraGraph in Normal Volunteers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neuromuscular Blockade

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • Volunteer meets the American Society of Anesthesiology (ASA) physical status I-III criteria
  • Volunteer has provided verbal informed consent

Exclusion criteria

  • 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.

Treatment and study plan

TetraGraph

Device

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 Watch

Device

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Noise level

    Time frame: During stimulation

    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).

  2. Stimulus artifact

    Time frame: During stimulation

    That the stimulus artifact will not obscure the EMG response when a stimulus is applied.

  3. Appearance EMG response

    Time frame: During stimulation

    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.

  4. EMG amplitude

    Time frame: During stimulation

    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.

  5. Maximal EMG amplitude

    Time frame: During stimulation

    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.

  6. Consistency in amplitude

    Time frame: During stimulation

    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.

  7. Discomfort level

    Time frame: During stimulation

    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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 23, 2016
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.