Electromyographic Assessment of the TetraGraph in Normal Volunteers
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Neuromuscular Blockade
- Sponsor
- Mayo Clinic
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Comparison of train of four measurements between TOF Watch and TetraGraph
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
J. Ross Renew, M.D.
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
- EMG amplitude(During stimulation)
- Discomfort level(During stimulation)
- Noise level(During stimulation)
- Stimulus artifact(During stimulation)
- Maximal EMG amplitude(During stimulation)
- Appearance EMG response(During stimulation)
- Consistency in amplitude(During stimulation)