Quantitative Assessment of Train of Four Device for Patients Receiving Neuromuscular Blockade
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Quantitative Amplitude of Force in the Neuromuscular Block Aid compared to the Qualitative Standard of Care Observations
研究概览
简要总结
The assessment of neuromuscular blockage is common practice in the operating room, in which such agents are employed. Still today, the use of simple hand held stimulators and visual monitoring of these responses are the norm. The investigators want to study the potential for employing a non-invasive quantitative device with built in sensors that will hopefully accurately determine the degree of neuromuscular blockade. This system utilizes commonly employed train of four (TOF) electrical stimulation pulses, an incorporated force sensor and an automated detection system. This system will not only utilized pre-blockade, but also throughout an entire surgical procedure and during reversal therapy. For comparisons, the investigators will use both the prototype device and a standard hand held TOF for the assessment of neuromuscular blockage. In other words, the planned protocol will involve testing the effectiveness and accuracy of the device concurrently with peripheral nerve stimulation, during a procedure as is done for the current standard of care. All protocols will be carried out under the direct guidance and supervision of anesthesiologists and/or nurse anesthetists.
详细描述
Project Summary:
In this study the investigators propose to evaluate a train of four (TOF) stimulator that assess the neuromuscular junction of a patient under anesthesia. The goal of this project is to evaluate a novel device in comparison to the standard of care with a hand held stimulator.
Background and Significance:
The assessment of neuromuscular blockage is common practice in the operating room, in which such agents are employed. Still today, the use of simple hand held stimulators and visual monitoring of these responses are the norm. The investigators now want to study the potential for employing a non-invasive quantitative device with built in sensors that will hopefully accurately determine the degree of neuromuscular blockade. This system utilizes commonly employed train of four (TOF) electrical stimulation pulses, an incorporated force sensor and an automated detection system. This system will not only utilized pre-blockade, but also throughout an entire surgical procedure and during reversal therapy. For comparisons, we will use both the prototype device and a standard hand held TOF for the assessment of neuromuscular blockage.
In other words, the planned protocol will involve testing the effectiveness and accuracy of the device concurrently with peripheral nerve stimulation, during a procedure as is done for the current standard of care. All protocols will be carried out under the direct guidance and supervision of anesthesiologists and/or nurse anesthetists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal, healthy subjects (adults) admitted for surgical procedures.
排除标准
- •Under 18 years of age or over 80 years of age, anesthetic paradigm does not include NMBAs.
研究组 & 干预措施
Safety and Efficacy
Parallel treatment; use of standard TOF peripheral Stimulator to Novel Train of Four Device
干预措施: Neuromuscular Block Aid (Device)
Safety and Efficacy
Parallel treatment; use of standard TOF peripheral Stimulator to Novel Train of Four Device
干预措施: Standard of Care: Microstim Plus (Device)
Microstim
A peripheral nerve stimulator, also known as a train-of-four monitor, is used to assess neuromuscular transmission when neuromuscular blocking agents (NMBAs) are given to block musculoskeletal activity. By assessing the depth of neuromuscular blockade, peripheral nerve stimulation/monitoring can ensure proper medication dosing and thus decrease the incidence of side effects. Peripheral nerve stimulation is most commonly used for ongoing monitoring in the intensive care unit (ICU).
干预措施: Standard of Care: Microstim Plus (Device)
Microstim
A peripheral nerve stimulator, also known as a train-of-four monitor, is used to assess neuromuscular transmission when neuromuscular blocking agents (NMBAs) are given to block musculoskeletal activity. By assessing the depth of neuromuscular blockade, peripheral nerve stimulation/monitoring can ensure proper medication dosing and thus decrease the incidence of side effects. Peripheral nerve stimulation is most commonly used for ongoing monitoring in the intensive care unit (ICU).
干预措施: Neuromuscular Block Aid (Device)
结局指标
主要结局
Quantitative Amplitude of Force in the Neuromuscular Block Aid compared to the Qualitative Standard of Care Observations
时间窗: 2 years
FDA clinical trials have utilized \~100-400 patients to determine the relative safety and efficacy of a medical device. Direct comparison of the devices qualitative evaluation of scoring from the administering anesthesiologist will be used for the final analysis. A peripheral nerve stimulator, used to elicit a train-of-four (TOF) response, allows the assessment of neuromuscular blockade. Subjectively they determine the relative depth by visualizing TOF responses.If the first and last stimulus in a TOF elicit no force, this indicates blockade, or if the TOF has equal amplitudes, this indicates no blockade or reversal. Return of muscle force is required before the patient can be extubated. Current peripheral nerve stimulators rely on visual subjective analysis of relative contractions, whereas our investigational device will provide a quantitative assessment of the amplitude of the muscle contraction in grams and percent amplitudes of measured forces relative to the first stimulus.
次要结局
未报告次要终点