Clinical Evaluation of a Novel Neuromuscular Blockade Monitoring System

NCT04406740 | Terminated FDA Device

• 1 other identifier: ANES-2020-28905
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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).

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Device: TwitchView EMG Unit; Device: Novel QTOF Device

Interventions

TwitchView EMG Unit DEVICE

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

All Participants

Novel QTOF Device 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).

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• \- 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

MHealth Farview University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Study Officials

• Michael Todd, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 28, 2020
• Study Start: June 18, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: February 22, 2023

Record last verified: 2023-02

Locations

US (1)