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Comparison of an Acceleromyography- and Electromyography-based Neuromuscular Monitor With TOF-Watch ® Monitor

Sponsor
Huazhong University of Science and Technology (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05632107
Collaborator
(none)
100
Enrollment
1
Location
36
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A quantitative neuromuscular monitoring device is desirable to titrate the depth of neuromuscular block (NMB) during a procedure, and to prevent residual effects after removal of the endotracheal tube. Unfortunately, the most widely used monitoring technique acceleromyography (AMG) typically implies a series of cumbersome installation and calibration procedures that frequently precludes correct use of these devices in clinical practice. Electromyography (EMG) has recently attracted a lot of attention as an alternative strategy to compensate for the deficiency of AMG-based neuromuscular monitors. Nowadays, a new technology that allows for the simultaneous acquisition of EMG and AMG signals is commercially available. Although its reliability has been rapidly accepted in Physical Medicine and Rehabilitation, the use of the technique in neuromuscular monitoring has never been reported. The aim of the present study is to assess the validity of the new device for estimating the neuromuscular block by comparing with TOF Watch®-SX, which is the most widely accepted AMG-based neuromuscular monitor that has been practiced in the clinical arena for decades.

Condition or Disease Intervention/Treatment Phase
  • Device: TOF-Watch®；DELSYS® Wireless surface EMG

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of an Acceleromyography- and Electromyography-based Neuromuscular Monitor With TOF-Watch ® Monitor：a Pilot Study
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Outcome Measures

Primary Outcome Measures

  1. Assessing the correlation between the train-of-four (TOF) obtained from the 2 devices [Perioperative data]

  2. Assessing the correlation between the posttetanic count (PTC) obtained from the 2 devices [Perioperative data]

Secondary Outcome Measures

  1. Screening for eligible individual signal sources from the multiplex information of the new technology for improving neuromuscular monitoring [Perioperative data]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age less than 18 yr

  • American Society of Anesthesiologists Physical Status I to III

  • Elective surgery requiring muscle relaxation

  • Patients participated voluntarily and signed informed consent

Exclusion Criteria:

  • Patients with known neuromuscular disorder

  • Stroke

  • Patients with a history of allergic reaction toneuromuscular blocking agents

  • Use of medications that might interfere with neuromuscular transmission

  • Any previous injury to the examined arm that might influence nerve conduction parameters

  • Pacemaker

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei China 430030

Sponsors and Collaborators

  • Huazhong University of Science and Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hua Zheng, Associate Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT05632107
Other Study ID Numbers:
  • TJMZK202201
First Posted:
Nov 30, 2022
Last Update Posted:
Dec 19, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hua Zheng, Associate Professor, Huazhong University of Science and Technology
neuromuscular blocking agents; residual neuromuscular blockade; neuromuscular monitoring; acceleromyography; electromyography

Study Results

No Results Posted as of Dec 19, 2022