Evaluate Functionality and Use of the NMT EasyFit Sensor and NMT EasyFit Cable
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Collection of End User Feedback Surveys
研究概览
简要总结
The purpose of this clinical study is to collect and assess feedback from clinical users regarding the functionality and device use and collection of raw parameter date from the NMT Sensor and NMT Cable.
详细描述
The NMT Sensor provides quantitative, automated measurements of neuromuscular block by delivering non-invasive electrical stimuli to the ulnar nerve and recording electromyography (EMG) responses from the adductor pollicis muscle. Surface hydrogel electrodes with adhesive foam ensure secure placement for continuous monitoring. The single-use sensor connects to a reusable NMT Cable and is designed for use with GE HealthCare NMT measurement devices (NMT Module and bedside monitors).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Study subject (male or female) is age 18 years or older (≥18 years).
- •Study subject must have the ability to understand and provide written informed consent.
- •Study subject is undergoing a clinically indicated procedure requiring the use of paralytic medication.
- •Study subject will have the primary NMT monitoring conducted using an NMT ElectroSensor on the hand/forearm.
排除标准
- •Are known to be pregnant.
- •Are breastfeeding.
- •Suffering from an infection(s) that requires isolation.
- •Deformity, scar tissue, tattoos, or other characteristics at the sensor application area that could interfere (e.g., nerve damage) with the completion of the study procedure or identify a study subject.
- •Subjects requiring rapid sequence induction
- •Subjects expected to be at risk from participation for any reason, such as those with known allergy or sensitivity to adhesive materials that may be used in the study.
- •Direct employees or contractors of GE HealthCare, or any company that makes NMT monitoring devices (sensors, cables, modules).
- •NMT ElectroSensor placed on the foot/ankle
研究组 & 干预措施
All Subjects
Placement of NMT Sensor on Hand and Forearm
干预措施: Collection of NMT Technology (Device)
结局指标
主要结局
Collection of End User Feedback Surveys
时间窗: Up to 24 hours
Collection of end user feedback surveys on the functionality and clinical use of the NMT Sensor and Cable during standard of care surgical procedure (minimum of 1 hour and maximum of 24 hours).
次要结局
- Collection of raw parameter data from NMT Sensor and Cable(Up to 24 hours)
- Incidence of Safety Events(4 months.)