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.

Study Overview

• Status: Completed
• Conditions: Neuromuscular Blockade
• Intervention / Treatment: Device: TetraGraph; Device: TOF Watch

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population for this study is normal, healthy, unpremedicated human volunteers.

Description

Inclusion Criteria

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

Exclusion Criteria

1. Presence of an underlying neuromuscular disease
2. Use of medications known to interfere with neuromuscular transmission
3. Volunteer has open sores/rashes at the locations needed for electrode application
4. Volunteer does not tolerate a trial electrical stimulation comfortably.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	During stimulation
Stimulus artifact	That the stimulus artifact will not obscure the EMG response when a stimulus is applied.	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.	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.	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.	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.	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	During stimulation

Collaborators and Investigators

• Sponsor: Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: September 21, 2016
• First Submitted That Met QC Criteria: September 22, 2016
• First Posted (Estimate): September 23, 2016

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 16-005022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No