Neurostimulation and Electromyographic Assessment of the TetraGraph (NEAT) In Patients (NEAT-3)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Primary performance assessment of TetraGraph device
研究概览
简要总结
TetraGraph is a newly developed EMG-based, quantitative, battery-powered neuromuscular monitoring system intended for daily clinical use. The primary aim of this clinical investigation is to examine the applicability (ease of use, equipment need, etc.), repeatability (precision or internal consistency) and performance (signal quality, accuracy of outcome, voltage of stimulation output before and during a stimulus) of the Tetragraph device in patients undergoing elective surgeries requiring neuromuscular blockade.
详细描述
The TetraGraph will be tested in 50 consenting patients undergiong elective surgeries requiring neuromuscular blockade. The left of right hand of the patients will be randomly studied. After the induction of anesthesia but before the administration of muscle relaxant train-of-four (TOF) stimulation will be started with 30 mA current intensity, 0.2 msec pulse duration at 20 sec intervals. The stimulation will be left to run until extubation. The TetraGraph device will be set not to show measurement results on the screen but save them on the SD card for later analysis. This way TetraGraph will not influence clinical decisions and patient care. During the operations we will record the number of muscle twitches in return to stimulation, the time and dose of muscle relaxant and opioid administration, the time of use of electrocautery and the skin temperature.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Age 18 years or older.
- •American Society of Anesthesiology (ASA) physical status I-III criteria (Table I).
- •Subject has provided written informed consent.
排除标准
- •Presence of an underlying neuromuscular disease.
- •Presence of renal or hepatic disease.
- •Subject has open skin sores in the locations needed for electrode application (forearms).
- •Patient is taking anti-seizure medication
- •Patient is taking oral anti-cholinesterase (e.g., therapy for myasthenia gravis)
- •Magnesium sulfate administration is required
结局指标
主要结局
Primary performance assessment of TetraGraph device
时间窗: participants will be followed for the duration of their hospital stay, an expected avarage of five days
The primary objective of this study is to provide safety \& performance data of the TetraGraph device in anesthetized patients. Performance will be assessed post hoc by analyzing objective EMG data from the SD card and correlating the responses to annotations made during the surgical procedure (e.g., correlating the EMG responses to the time of NMBA or reversal agent administration). No clinical decisions will be made based on any objective measurements made by the TetraGraph. There are no specific timepoints concerning the primary outcome measure of the study.
次要结局
- Safety of TetraGraph device(participants will be followed for the duration of hospital stay, an expected avarage of 5 days)
- Secondary performance assessment of TetraGraph Device(participants will be followed for the duration of the hospital stay, an expected avarage of 5 days)
研究者
Tamas Vegh, MD
MD, PHD
University of Debrecen