Comparative Assessment of Neuromuscular Blockade Monitors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Washington
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Train-of-four count
Study Overview
Brief Summary
The overall objective of this research is to evaluate different laboratory-built and commercially available sensors used to measure the effects of neuromuscular blocking drugs on neuromuscular function during surgery, by measuring evoked thumb twitch response to ulnar nerve stimulation (also known as "twitch monitoring"). The specific aim is to compare mechanomyography, which is the "gold standard" laboratory measurement to assess neuromuscular blockade, to the sensors used in commercially available neuromuscular blockade monitors, such as acceleromyography and electromyography. The study endpoints are the train-of-four count (TOFC), the ratio of the height of the 4th twitch to the height of the 1st twitch (train-of-four ratio, TOFR), and the post tetanic count (PTC). The mechanomyography devices have been constructed in our laboratory and are not commercially available.
Detailed Description
Twitch monitoring will be performed as described below for each device:
Stimpod NMS 450 or other related Stimpod device (Xavant Technology, Pretoria, South Africa)--acceleromyography and/or electromyography. Movement of the thumb and hand will not be restricted and no artificial preload will be used. Electrodes (3M Red Dot, 3M Healthcare, St. Paul, MN, USA) will be applied over the ulnar nerve at the wrist for acceleromyography. The Stimpod acceleromyography sensor will be attached to the distal phalanx of the thumb using the supplied plastic circumferential band, reinforced with tape if necessary. The Stimpod electromyography printed electrode array will be applied as described in the manufacturer's instructions for use.
TwitchView Monitor (Blink Device Company, Seattle, WA, USA)--electromyography. The TwitchView electromyography printed electrode array will be applied as described in the manufacturer's instructions for use.
TetraGraph (Senzime, Sweden)--electromyography. The TetraGraph electromyography printed electrode array will be applied as described in the manufacturer's instructions for use.
Nihon Kohden (Japan)--electromyography. The Nihon Kohden printed electromyography electrode array will be applied as described in the manufacturer's instructions for use.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years of age or greater
- •Undergoing anesthesia that requires neuromuscular blocking drugs
Exclusion Criteria
- •Less than 18 years of age
- •Undergoing anesthesia that does not require neuromuscular blocking drugs
- •Undergoing a procedure in which access to one or both arms is limited
- •Anatomical abnormalities of the hands or arms that preclude twitch monitoring with ulnar nerve stimulation and evoked thumb twitch response
Outcomes
Primary Outcomes
Train-of-four count
Time Frame: Procedure (from the induction of anesthesia until emergence of anesthesia)
Counting evoked thumb twitch response to ulnar nerve stimulation
Train-of-four ratio
Time Frame: Procedure (from the induction of anesthesia until emergence of anesthesia)
Ratio of the height of the 4th thumb twitch to the height of the 1st thumb twitch after ulnar nerve stimulation
Post tetanic count
Time Frame: Procedure (from the induction of anesthesia until emergence of anesthesia)
The number of twitches (0-15) following a tetanic stimulus
Twitch count by palpation
Time Frame: Procedure (from the induction of anesthesia until emergence of anesthesia)
The twitch count is determined by palpation of the thumb
Train-of-four Ratio
Time Frame: Procedure (from the induction of anesthesia until emergence of anesthesia)
Determine evoked thumb twitch response to ulnar nerve train-of-four stimulation then determine the ratio of the amplitude of the fourth twitch divided by the first twitch, referred to as the train-of-four ratio. The train-of-four ratio is expected to be 1.0 in the absence of neuromuscular blocking drugs. The range of possible train-of-four ratios is 0-1.6. Results that deviate from a train-of-four ratio of 1.0 represent inaccuracy of the measurement.
Secondary Outcomes
No secondary outcomes reported
Investigators
T. Andrew Bowdle
Professor, School of Medicine
University of Washington