Novel Stimulation to Improve Respiratory Function in ARDS and Severe COVID-19 Patients

改善 ARDS 和重症 COVID-19 患者呼吸功能的新刺激

• 批准号: 10483910
• 负责人: Bill Hardin
• 金额: $ 27.54万
• 依托单位: RESTORE TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10483910
• 关键词: Acute; Acute Respiratory Distress Syndrome; Admission activity; Affect; Atrophic; Brain Stem; Breathing; COVID-19; COVID-19 patient; California; Cervical spinal cord injury; Cervical spine; Cessation of life; Chronic; Clinic; Complex; Complication; Consumption; Dangerousness; Data; Dependence; Development; Development Plans; Device or Instrument Development; Devices; Disease; Doctor of Philosophy; Economics; Electric Stimulation; Electrodes; Evoked Potentials; Excision; Feasibility Studies; Frequencies; Functional disorder; Goals; Health Services Accessibility; Human; Implant; Infection; Injury; Intensive Care Units; Intubation; Laryngeal Injury; Lead; Life; Los Angeles; Magnetism; Mechanical Ventilators; Mechanical ventilation; Medical; Methods; Morbidity - disease rate; Muscle; Muscular Atrophy; Nature; Neurons; Neurostimulation procedures of spinal cord tissue; Operative Surgical Procedures; Orthopedic Surgery; Pathway interactions; Patients; Periodicity; Phase; Physiologic pulse; Pilot Projects; Pneumonia; Process; Protocols documentation; Quality of life; Recovery; Rehabilitation Centers; Rehabilitation therapy; Resources; Respiration; Respiratory Diaphragm; Respiratory Failure; Respiratory Muscles; Respiratory physiology; Safety; Sensory; Series; Small Business Innovation Research Grant; Source; Spinal; Spinal Cord; Spine surgery; Structure of phrenic nerve; System; Techniques; Technology; Testing; Therapeutic; Tidal Volume; Time; Transcutaneous Electric Nerve Stimulation; Translating; United States; Universities; Update; Ventilator; Weaning; Work; base; cohort; conditioning; deconditioning; design; disability; experimental study; improved; innovation; lung injury; mid-career faculty; mortality; motor recovery; neural circuit; neural network; neuromechanism; neuroregulation; neurosurgery; novel; pandemic coronavirus; pandemic disease; prevent; prototype; relating to nervous system; research and development; respiratory; response; restoration; safety and feasibility; safety study; sensory input; severe COVID-19; social; ventilation

PROJECT SUMMARY/ABSTRACT Acute respiratory distress syndrome (ARDS) is an often-fatal form of respiratory failure. Relevant to the recent coronavirus pandemic, the majority of patients with severe Coronavirus Disease of 2019 (COVID-19) develop ARDS and need mechanical ventilation and ICU admission, placing severe strains on the medical system. Use of mechanical ventilation (MV) during ARDS for cases such as COVID-19 is supportive until the infection has resolved which may take up to 20 days. While MV is useful for ventilation and supporting life, it causes severe atrophy of respiratory muscles that delays extubation. Furthermore, prolonged MV causes substantial morbidity and mortality (i.e. lung injury, pneumonia, laryngeal injury, etc.) Therefore, strategies to condition the respiratory muscles to prevent atrophy during intubation will likely decrease MV time, thereby decrease morbidity and mortality associated with MV, and decrease ventilator need and consumption of valuable resources. Strategies have been developed to condition or activate the diaphragm muscle during chronic high cervical spinal cord injury with implants that stimulate the phrenic nerve or diaphragm; however, such an invasive strategy is incompatible with the acute and temporary nature of ARDS. The main hurdle to accessing the neural network for breathing for therapeutic purposes is that the neural mechanisms controlling respiration reside deep in the brainstem, which is dangerous to access surgically. Recently, we elucidated a novel breathing pathway that can be modulated by stimulation of the spinal cord. We have compiled significant data demonstrating that this strategy can restore or augment breathing. The main objective of this project is to provide safety and feasibility data for this approach in patients with ARDS. The second objective is to provide proof of the concept that this strategy can improve respiratory function in ventilator-dependent patients and define the stimulation parameters that most effectively prevent respiratory muscle atrophy during MV. The deliverables for this project include establishing the safety and feasibility of transcutaneous spinal stimulation for respiratory rehabilitation in ARDS, preliminary efficacy data, refining the prototype design, and creating support for subsequent phases of device development.

项目摘要/摘要 急性呼吸窘迫综合征（ARDS）是一种呼吸衰竭的一种致命形式。与最近的 冠状病毒大流行，大多数2019年严重冠状病毒疾病（Covid-19）的患者发展 ARDS和需要机械通气和ICU入院，在医疗系统上施加严重的菌株。使用 诸如COVID-19等病例的ARDS期间的机械通气（MV）是支持感染的支持 解决可能需要20天的时间。虽然MV对通风和支持生活有用，但会导致严重 延迟拔管的呼吸肌肉萎缩。此外，延长的MV会导致大量发病率 因此 在插管过程中预防萎缩的肌肉可能会减少MV时间，从而降低发病率和 与MV相关的死亡率，减少呼吸机的需求和消耗宝贵资源。 在慢性高颈椎期间已经制定了策略来调节或激活隔膜肌肉 用植入物刺激神经或隔膜的绳索损伤；但是，这种侵入性策略是 与ARDS的急性和暂时性不相容。访问神经网络的主要障碍 用于治疗目的的呼吸是控制呼吸的神经机制深处 脑干，这是危险的手术。最近，我们阐明了一种新颖的呼吸途径 通过刺激脊髓调节。我们已经编制了重要的数据，证明了这一点 策略可以恢复或增加呼吸。该项目的主要目的是提供安全性和可行性 ARDS患者中这种方法的数据。第二个目标是提供证明这一点的概念 策略可以改善依赖呼吸机依赖性患者的呼吸功能，并定义刺激参数 最有效地防止MV期间呼吸肌萎缩。该项目的可交付成果包括 建立经皮脊柱刺激对ARDS呼吸康复的安全性和可行性， 初步疗效数据，完善原型设计并为设备的后续阶段提供支持 发展。