Validation of a Muscle Relaxation Monitor

Study Overview
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Brief Summary
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The objective of this study is to determine the accuracy of a hydraulically coupled twitch monitor compared to the EMG twitch monitor in current use to measure the extent of neuromuscular blockade in patients undergoing general anesthesia.

Detailed Description
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Neuromuscular blockade (paralysis) is necessary for many surgical procedures to provide optimal surgical conditions. The extent of paralysis typically assessed during routine clinical care by examining the muscle response of the thumb (twitch) following delivery of a series of the train-of-four. Quantitative assessment of neuromuscular block can be assessed using electromyography (EMG) This technique measures action potential in the muscles of the thumb. The proposed method is a simple technique that can constructed with equipment that is readily available in most operating rooms. If validated, it would provide a simple method to assess quantitatively the extent of neuromuscular blockade and recovery of muscle strength.

Official Title
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Validation of a Device to Monitor Muscle Relaxation During Surgery

Conditions
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Neuromuscular Blockade

Intervention / Treatment
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* Device: Hydraulic Monitoring Device
* Device: Standard EMG Monitoring Device


Participation Criteria
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Eligibility Criteria
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Age >18 Surgery is elective Subject has been NPO for fluids for >2 hours and for solids >8 hours General anesthesia with tracheal intubation is required Mask ventilation is expected to be without difficulty Subject voluntarily consents in writing to the protocol ASA Physical Status 1-III (healthy individuals, those with mild comorbid conditions, or those with more serious co-morbid conditions that are well controlled) Exclusion Criteria: Lack of ability to provide written, informed consent Airway examination indicates a likelihood of difficult mask ventilation Symptoms of active reflux at the time of induction, at risk of having food in their stomach at the time of induction, expected abnormal response to non-depolarizing neuromuscular blockers Age ≤18 years Pregnant women Presence of carpal tunnel syndrome Prisoners General anesthesia not being provided Tracheal intubation will not be performed Anticipated length of surgery <60 minutes Emergent or urgent surgery Disease that might alter the normal neuromuscular response to electrical stimulation (e.g., muscular dystrophies, myasthenia gravis, quadriplegia). ASA Physical Status IV or V (individuals with major comorbid conditions that are a constant source of risk to health)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydraulic Monitoring Device<br>Monitoring device to be compared to electromyographic (EMG) device in the same patient; measures depth of neuromuscular blockade during general anesthesia based on the pressure exerted by the muscles of the thumb. | Device: Hydraulic Monitoring Device<br>* The hydraulic monitoring device externally measures the pressure associated with thumb strength applied to the device to determine the depth of neuromuscular blockade during general anesthesia. This will be compared to measurements using a current monitoring device in the same patient.<br>|
| Active Comparator: Standard EMG Monitoring Device<br>Currently used standard monitoring device; measures depth of neuromuscular blockade during general anesthesia based on the action potential of the muscles of the thumb. | Device: Standard EMG Monitoring Device<br>* Standard and in current usage, the electromyographic monitoring (EMG) device externally measures the action potential of the muscles of the thumb to determine the depth of neuromuscular blockade during general anesthesia. This will be used as the clinical monitoring device and as a comparator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Hydraulic Twitch Monitoring Device in Measuring Neuromuscular Blockade as Compared to EMG Monitoring Device, Assessed using Repeated Measures Bland-Altman Analysis | To determine the accuracy (bias and precision) of a the monitoring device as compared to the electromyographic (EMG) monitor in measuring the extent of neuromuscular blockade in subjects undergoing general anesthesia. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anesthesiology, neuromuscular blockade, monitoring device