Closed Loop Electrical Muscle Stimulation System (CL-EMS) with improved safety for ICU environment to mitigate ICU Acquired Weakness

闭环电肌肉刺激系统 (CL-EMS) 提高了 ICU 环境的安全性，以减轻 ICU 获得性弱点

• 批准号: 10545702
• 负责人: Oussama Hassan
• 金额: $ 25.95万
• 依托单位: HEALTH DISCOVERY LABS LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10545702
• 关键词: Acute; Address; Admission activity; Adoption; Adrenal Cortex Hormones; Affect; Antibiotics; Bed rest; Cardiac; Characteristics; Clinical; Clinical Data; Critical Illness; Devices; Direct Costs; Electric Stimulation; Electrocardiogram; Electrodes; Electromagnetics; Electronics; Environment; Equipment; Exercise; Exposure to; External Defibrillator; Feedback; Frequencies; Functional disorder; Goals; Health; Healthcare Systems; Hospitalization; Hour; Inflammatory; Intervention; Length of Stay; Life; Limb structure; Literature; Lower Extremity; Measurement; Mechanical ventilation; Medical Device; Monitor; Morphologic artifacts; Muscle; Muscle Contraction; Neuromuscular Blocking Agents; Noise; Patients; Pharmacology; Phase; Physical therapy; Physiologic pulse; Physiological; Preventive measure; Process; Quality of life; Reaction; Reading; Recommendation; Rehabilitation therapy; Resolution; Respiratory Muscles; Risk; Safety; Signal Transduction; Site; Skin; Specific qualifier value; Suggestion; Surface; System; Systems Integration; Testing; Time; Validation; Weaning; Work; Workload; bioelectricity; cardiac implant; compliance behavior; design; effective therapy; electric impedance; functional disability; healthy volunteer; human subject; improved; interest; intervention cost; mortality; muscle strength; neuromuscular; prevent; programs; prototype; quadriceps muscle; research and development; response; safety study; safety testing; success; tool

Project Summary/Abstract The goal of the project is to develop a closed loop electrical muscle stimulation (CL-EMS) system to mitigate ICU acquired weakness (ICUAW). Multifactorial in origin (extended period of bed rest, acute inflammatory state, exposure to multiple pharmacological agents such as neuromuscular blockers, antibiotics, and corticosteroids), ICUAW starts within few hours of ICU admission, affects the limbs, particularly the lower extremities as well as the respiratory muscles impeding weaning from mechanical ventilation, leading to prolonged hospitalization and eventual short-term and long-term functional impairment and reduced quality of life. Currently, no effective treatment exists for ICUAW, and the focus is primarily on early mobility preventive measures. Current early mobility program is executed by physical therapy and requires patient’s cooperation and could not be performed immediately after ICU admission in critically ill/mechanically ventilated patients. Therefore, there is high interest in being able to intervene early via non-volitional exercise strategies. One such promising strategy is “Electrical Muscle Stimulation” (EMS). EMS passively activates muscles using skin-surface electrodes and electrical pulses. Clinical data from the literature support the use of EMS as a tool for early rehabilitation. However, technical limitations prevented widespread adoption of EMS in ICUs: (1) no EMS device is developed for ICU use raising safety questions related to electromagnetic interference (EMI) with cardiac monitoring systems as well as life sustaining equipment such as cardiac implanted electronic devices and external defibrillators; (2) the continuous presence of a skilled operator on site to set up the device and continuously monitor the treatment session (by assessing physiological feedback from the patient and making adjustments) increase the workload and cost of the intervention. We reasoned that an EMS device with low electric noise could reduce the risk of EMI. Additionally, we reasoned that using real-time muscle bioelectric feedback in response to electric stimulation could create the basis for a closed loop system. A low noise EMS system showed promising results when tested with an ECG system. In addition, we find that the use of real-time bioelectric feedback is reliable in detecting muscle response to electrical stimulation. Therefore, in this project we will integrate a bioelectric feedback device with a low noise EMS device to create a CL-EMS α-version that is safe for use in ICU setting. In phase 1 R&D work related to the electrical design integration of the closed loop prototype system will be completed. An α-version of the CL-EMS system will be built and tested for safety and efficacy in inducing an effective muscle contraction. The validation process will include IEC testing and testing in healthy volunteers.

项目总结/摘要 该项目的目标是开发一种闭环电肌肉刺激（CL-EMS）系统，以减轻ICU 获得性虚弱（ICUAW）。多因素起源（长期卧床、急性炎症状态， 暴露于多种药物如神经肌肉阻滞剂、抗生素和皮质类固醇）， ICUAW在ICU入院后几小时内开始，影响四肢，特别是下肢， 呼吸肌阻碍脱离机械通气，导致住院时间延长， 最终导致短期和长期功能障碍和生活质量下降。目前，没有有效的 ICUAW有治疗方案，重点主要是早期行动预防措施。当前早期 通过物理治疗执行移动程序，需要患者配合，无法执行 重症/机械通气患者入住ICU后立即进行。因此，高 有兴趣能够通过非意志性锻炼策略进行早期干预。其中一个有希望的策略是 肌肉电刺激（EMS）。EMS使用皮肤表面电极被动地激活肌肉， 电脉冲来自文献的临床数据支持使用EMS作为早期康复的工具。 然而，技术限制阻碍了EMS在ICU中的广泛采用：（1）没有开发EMS设备 用于ICU引起了与心脏监测电磁干扰（EMI）相关的安全性问题 系统以及生命维持设备，例如心脏植入式电子设备和外部 （2）熟练的操作人员在现场连续设置设备， 监测治疗过程（通过评估患者的生理反馈并进行调整） 增加干预的工作量和成本。我们推断，具有低电噪声的EMS设备可以 降低EMI的风险。此外，我们推断，使用实时肌肉生物电反馈来响应 电刺激可以为闭环系统奠定基础。低噪声EMS系统显示出良好的应用前景 使用ECG系统测试时的结果。此外，我们发现，使用实时生物电反馈是 可靠地检测肌肉对电刺激的反应。因此，在本项目中，我们将整合一个 生物电反馈装置与低噪声EMS装置，以创建可安全用于ICU的CL-EMS α版本 设置.在第一阶段，与闭环原型系统的电气设计集成相关的研发工作将 完成。将构建CL-EMS系统的α版本，并测试其在诱导 有效的肌肉收缩。确认过程将包括IEC测试和健康志愿者测试。