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.

项目总结/文摘