Electromyographic Assessment of the TetraGraph in Normal Volunteers

NCT02912039 | Completed

• 1 other identifier: 16-005022
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Noise level

  During stimulation

• Stimulus artifact

  During stimulation

• Appearance EMG response

  During stimulation

• EMG amplitude

  During stimulation

• Maximal EMG amplitude

  During stimulation

Interventions

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 23, 2016
• Study Start: September 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: May 17, 2023

Record last verified: 2018-07

Locations

US (1)