NCT04406740

Clinical Evaluation of a Novel Neuromuscular Blockade Monitoring System

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 9 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to formally evaluate the performance of the QTOF, as compared with the newest commercially available NMB monitoring equipment, EMG (the TwitchView).

Detailed description

The disposable stimulus/recording electrode array for the TwitchView will be placed on one of the patient's wrist/hand and connected to the device. Next, the stimulating electrodes and vibration sensor of the QTOF device will be placed over the contralateral ulnar nerve and thenar eminence. The devices will be placed prior to the induction of anesthesia - but no electrical stimuli will be delivered until AFTER the patient is asleep (as per routine). After induction, both devices will be started. The TwitchView automatically selects the appropriate stimulus current (takes about 10 seconds) - and when that is complete, the QTOF stimulus current will be set to the same value. The stimulus interval for both devices will be 20 seconds. Paired measurements of twitch count and TOF ratios will be gathered for the entirety of the surgical procedure, and cross checked with Epic regarding the administration of neuromuscular blocking drugs (time, dose) and reversal agents (time, dose). RAs will be present to verify the correct function of both devices. Note that information from the TwitchView monitor will be continuous available to the providers (it is a standard device available for use in our ORs). Information from the QTOF will NOT be made available to providers.

Conditions

• Anesthesia

Interventions

Type	Name	Description
DEVICE	TwitchView EMG Unit	The TwitchView device is a new generation electromyographic monitor that uses a disposable electrode array that combines stimulating and recording electrodes.
DEVICE	Novel QTOF Device	The QTOF consists of an electrical stimulator that is just like the stimulator in the traditional TOF devices that are commonly used (both accelerometric and EMG-based), combined with a novel sensor that sticks to the belly of the muscle being measured (most commonly the adductor pollicis, the thumb muscle in the palm of the hand).

Timeline

• Start date: 2018-06-18
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2020-05-28
• Last updated: 2023-02-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study