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

Официальное название

Comparison of an Acceleromyography- and Electromyography-based Neuromuscular Monitor With TOF-Watch ® Monitor：a Pilot Study

Обзор

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.

Вмешательства

• Устройство TOF-Watch®；DELSYS® Wireless surface EMG
  TOF-Watch® is the most widely accepted AMG-based neuromuscular monitor; and DELSYS® Wireless surface EMG is a new technology that allows for the simultaneous acquisition of EMG and AMG signals in a wireless manner.

Первичные конечные точки

• Assessing the correlation between the train-of-four (TOF) obtained from the 2 devices [Срок оценки: Perioperative data]
• Assessing the correlation between the posttetanic count (PTC) obtained from the 2 devices [Срок оценки: Perioperative data]

Вторичные конечные точки (1)

• Screening for eligible individual signal sources from the multiplex information of the new technology for improving neuromuscular monitoring [Срок оценки: Perioperative data]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 2 центра

• Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong Univers — Ухань
• Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University — Ухань

Идентификаторы

NCT: NCT05632107 · TJMZK202201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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