Clinical Evaluation of a Novel Neuromuscular Blockade Monitoring System

Anesthesia Clinical Trial

Official title:

Clinical Evaluation of a Novel Neuromuscular Blockade Monitoring System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04406740
• Other study ID #: ANES-2020-28905
• Status: Terminated
• Start date: June 18, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: February 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients scheduled to undergo any elective procedure under general anesthesia in the MHealth East Bank operating rooms in which the administration of a nondepolarizing neuromuscular blocking drug (rocuronium or cisatracurium) is anticipated

Exclusion Criteria:

• Emergent procedures will be excluded
• Procedures performed outside of regular Monday to Friday working hours will be excluded
• Inability to provide their own consent

Related Conditions & MeSH terms

• Anesthesia

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	MHealth Farview University of Minnesota Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Train-of-Four (TOF) Ratio	The train-of-four ratio (unitless measure) is calculated by comparing the magnitude of the fourth evoked response or twitch (T4) to that of the first response (T1).	420 minutes