Clinical Evaluation of a Novel Neuromuscular Blockade Monitoring System

NCT ID: NCT04406740

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 9 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-18
• Study Completion Date: 2021-06-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All Participants

Adult patients \>18 years of age, who are 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.

TwitchView EMG Unit

Intervention Type: DEVICE

The TwitchView device is a new generation electromyographic monitor that uses a disposable electrode array that combines stimulating and recording electrodes.

Novel QTOF Device

Intervention Type: 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).

Interventions

TwitchView EMG Unit

The TwitchView device is a new generation electromyographic monitor that uses a disposable electrode array that combines stimulating and recording electrodes.

Intervention Type: 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).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Todd, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

MHealth Farview University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

ANES-2020-28905

Identifier Type: -

Identifier Source: org_study_id