Comparison of Electromyography-based TetraGraph and Acceleromyography-based TOF-Watch SX Neuromuscular Monitors Under Clinical Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Agreement between acceleromyography and electromyography derived TOF ratios in the recovery range of 0.8-1.0
研究概览
简要总结
Anesthesiologists are often required to give certain drugs, called muscle relaxants to the patients for surgery. These drugs make the people weak for the procedure to make the work of the surgeon easier and prevent unexpected movements. The effect of these drugs must be terminated by the end of the procedures to ensure that the patients can breathe normally. Over the years several monitors have been developed to monitor the effect of these drugs. The monitors use different principles to measure muscle function. Some monitors are integrated into anesthesia machines while others are battery-operated, portable devices. The aim of the present study is two compare monitors using different technologies. Both monitors stimulate a peripheral nerve at the wrist that makes the thumb twitch. The older device (TOF-Watch SX) measures the acceleration of thumb movement, the new device (TetraGraph) measures the electrical activity of the muscle that moves the thumb. The two devices will be connected so that with one simulation both types of signals can be recorded and analyzed. The monitors will be used during the surgeries as described by the manufacturer. The study will not influence the surgical procedure or the anesthetic of the patients. The aim of the study is to collect data on how the two monitors correlate, since they measure neuromuscular function by different technologies (acceleromyography and electromyography).
详细描述
The aim of this single center, one-arm, observational, prospective, non-inferiority study is to compare neuromuscular data obtained with two neuromuscular monitors. The two monitors are the electromyography-based TetraGraph neuromuscular monitor and the acceleromyography-based TOF-WATCH SX device.
The study will enroll 50 patients undergoing elective surgeries that require muscle relaxation. Patients will be only enrolled after written informed consent is obtained. Exclusion criteria include: neuromuscular disease in patient history, patient taking any medication that affects neuromuscular transmission, open wound or sores at the site of electrode placement, expected difficult airway, pregnancy or breastfeeding state, or implanted pacemaker.
The study will be conducted using one of the patient's arms. Both neuromuscular monitors will be applied on the same arm. The monitors will be connected by optical cable link to synchronize nerve stimulation and data recording. The aim of this setting is to obtain both acceleromyography and electromyography signals of the adductor pollicis muscle in response to ulnar nerve stimulation. This setting ensures identical stimulation conditions for the two monitors. Only the TOF-Watch SX will be used for nerve stimulation while the TOF-Watch will collect acceleromyography data of the thumb and TetraGraph will collect the electromyography data of the adductor pollicis muscle.
The ulnar nerve will be stimulated via single use electrocardiography electrodes used by TOF-Watch SX. The piezoelectric probe of TOF-Watch SX will be applied on the thumb via hand adapter, according to the manufacturer's instructions. The stimulating electrodes of TetraGraph will be isolated, since the device will not deliver electrical stimulation, only register the compound muscle action potentials of the adductor pollicis muscle evoked by TOF-Watch SX stimulation. The sensing electrodes of TetraGraph will be applied above the thenar and the interphalangeal joint of the thumb.
The TetraGraph monitor used for the study has a modified software compared to the commercially available monitors. This study device is used only for the current study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective surgery requiring neuromuscular blockade
- •written informed consent
- •American Society of Anesthesiology physical status I-III
排除标准
- •neuromuscular disease in patient history,
- •patient taking any medication that affects neuromuscular transmission,
- •open wound or sores at the site of electrode placement,
- •expected difficult airway,
- •pregnancy or breastfeeding state,
- •implanted pacemaker
结局指标
主要结局
Agreement between acceleromyography and electromyography derived TOF ratios in the recovery range of 0.8-1.0
时间窗: Prior to extubation
Agreement between acceleromyography and electromyography derived TOF ratios in the recovery range of 0.8-1.0
次要结局
- o Agreement between acceleromyography and electromyography derived TOF ratios in the recovery range of 0.6-0.79(During surgery)
- o Agreement between acceleromyography and electromyography derived TOF ratios in the recovery range of 0.4-0.59(During surgery)
- o Agreement between acceleromyography and electromyography derived TOF ratios in the recovery range of 0.2-0.39(During surgery)
- o Agreement between acceleromyography and electromyography derived TOF counts(During surgery)
- o Agreement between acceleromyography and electromyography derived PTC counts(During surgery)
研究者
Tamas Vegh, MD
associate professor
University of Debrecen