跳至主要内容
临床试验/NCT06792058
NCT06792058已完成不适用

Comparative Study of TetraGraph and Mechanomiograph Neuromuscular Monitors in Clinical Settings

University of Debrecen1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1月2日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
concordance of the two devices

研究概览

简要总结

Background: Neuromuscular monitoring plays a critical role in reducing postoperative residual neuromuscular blockade (PRNB), a significant risk factor for respiratory complications. Despite the availability of various monitoring techniques, the validation of newer devices remains an ongoing challenge. This study compares the performance of the electromyography (EMG)-based Tetragraph neuromuscular monitor with the gold standard mechanomyography (MMG) device, focusing on their accuracy and reliability in clinical settings.

Methods: Twenty cases were conducted during general surgeries requiring neuromuscular relaxation. Ulnar nerve was stimulated via the Tetragraph which detected the compound muscle action potential (CMAP) of adductor pollicis muscle. Simultaneously on the same arm the isometric force of the same stimulated muscle was registrated by the MMG and displayed in the Labchart 8 program. Bland-Altman analysis was used to describe the agreement between devices during distinct phases of neuromuscular blockade. The primary endpoint of the study was the comparison of TOF values of MMG and EMG during induction. In recovery, two groups were made from TOFRs: below and above the recommended muscle recovery to exclude PRNB (TOFR≥90%) (Fuchs-Buder 2023). Additionally, in deeper neuromuscular blockade Train-of-Four Count (TOFC), and Post-Tetanic Count (PTC) values were also analysed.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 or over.
  • ASA (American Society of Anesthesiology) physical status I-III.
  • Informed written consent.
  • Surgery requires the use of a moderate-duration muscle relaxant.

排除标准

  • History of neuromuscular disease (e.g. stroke with hemi symptoms, myasthenia gravis, severe polyneuropathy).
  • Medication affecting neuromuscular transmission.
  • Open wound or rash due to electrode position
  • Expected difficult intubation.
  • Pregnancy, breast-feeding.
  • Implanted pacemaker

结局指标

主要结局

concordance of the two devices

时间窗: Intraoperativ

The primary endpoint of the study is the comparison of TOF values measured by mechanomyography and electromyography, and the examination of the measurement concordance of the two devices.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tamas Vegh, MD

MD PhD

University of Debrecen

研究点 (1)

Loading locations...

相似试验