Entrainment-based mechanical ventilation to improve patient-ventilator synchrony

基于夹带的机械通气可改善患者与呼吸机的同步性

• 批准号: 9144423
• 负责人: CHI-SANG POON
• 金额: $ 24.88万
• 依托单位: MASSACHUSETTS INSTITUTE OF TECHNOLOGY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-15 至 2018-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9144423
• 关键词: Accident and Emergency department; Acute; Acute respiratory failure; Address; Adult Respiratory Distress Syndrome; Age; Award; Basic Life Support; Bennett model; Biomedical Engineering; Brain; Breathing; Chronic; Clinical; Clinical Research; Clinical Trials; Collaborations; Complex; Computer software; Coupled; Cross-Over Studies; Dancing; Dependency; Devices; Economic Inflation; Effectiveness; Eligibility Determination; Engineering; Environmental air flow; FDA approved; Future; Generations; Goals; Grant; Health Care Costs; Home environment; Hospitalization; Hour; Incidence; Individual; Intensive Care Units; Interdisciplinary Study; Intuition; Investigation; Lead; Learning; Legal patent; Length of Stay; Letters; Life; Long-Term Care; Lung; Mechanical Ventilators; Mechanical ventilation; Mediating; Medical; Memory; Modeling; Multicenter Trials; Muscle; National Heart, Lung, and Blood Institute; Nosocomial Infections; Operating Rooms; Outcome; Paralysed; Patients; Persons; Phase; Phase III Clinical Trials; Physics; Pilot Projects; Probability; Procedures; Reflex action; Rehabilitation therapy; Research; Research Design; Research Personnel; Respiratory Failure; Risk; Safety; Secure; Sedation procedure; Slave; Techniques; Technology; Testing; Tracheostomy procedure; Translating; United States National Institutes of Health; Ventilator; Ventilator Weaning; Weaning; Work of Breathing; base; computerized; cost; cost effective; design; improved; innovation; mortality; next generation; novel; patient population; prospective; prototype; public health relevance; research clinical testing; respiratory; risk minimization; safety and feasibility; simulation; theories

 DESCRIPTION (provided by applicant): A fundamental question during assisted ventilation in the ICU is how to synchronize the ventilator rhythm with the patient's breathing effort smoothly and effectively. Dyssynchrony could lead to increased/wasted work of breathing, patient discomfort, increased need for sedation, higher rate of tracheostomy, longer durations of mechanical ventilation and reduced number of ventilator-free days, longer ICU and hospital stay, and lower probabilities of survival and home discharge. Current generation ventilators either dictate the breathing rhythm completely with the use of heavy sedation/muscle paralysis (ventilator-based ventilation) or let the patient trigger the ventilator breath by breath (patient-based ventilation). Neither extreme is optimal. We propose a next generation of ventilatory assist (entrainment-based mechanical ventilation, EMV) that is based on the classical physics theory of mutual entrainment between coupled oscillators, which may provide a cost-effective solution to this clinical problem. This innovative technique is motivated by our recent discovery that the brain circuits controlling breathing are capable of entraining to a ventilator and adaptin to it through learning and memory of the Hering-Breuer inflation reflex. In EMV, the patient's spontaneous respiratory rhythm and the ventilator rhythm are phase-locked to one another on the same tempo, just like two individuals dancing together. Under a previous NIH ARRA Challenge Grant (RC1) award we have implemented a prototype of EMV on a widely used mechanical ventilator (Puritan-Bennett Model 840) and demonstrated the feasibility of this novel technique on a computerized lung simulator. Based on these simulation results, a conditional approval for investigational device exemption has been recently granted by the FDA for initial clinical research of the EMV mode. To transition the base technology from the bench top to the bedside, a multidisciplinary research team comprised of a basic researcher/bioengineer (Dr. Poon, PI), a clinician (Dr. Harris, Co-I), a biostatistician (Dr. Schoenfeld, statistical consultan) and a technology developer (Covidien/Puritan-Bennett) has been formed to address the underlying scientific, engineering, statistical and clinical problems. The goal of this pilot projet is to first establish that the proposed EMV mode is both safe and effective in entraining the patient's breathing rhythm over a short (4-hour) period (Aim 1). This phase I clinical research wil allow us to fine-tune the parameters of the EMV mode in order to further minimize risks and maximize the effectiveness of the EMV mode in improving patient-ventilator synchrony over a long period. The second phase (Aim 2) is to establish that the EMV mode is safe and feasible in providing improved synchrony in ARDS patients when used over a patient's entire ventilation weaning period. The proposed phase I/phase II research are both necessary and sufficient for securing FDA approval of a full-scale phase III multicenter trial to be conducted in the future in order to test whether improved patient-ventilator synchrony with the EMV mode may lead to materially beneficial clinical outcomes during ventilator weaning.

 描述（由适用提供）：ICU辅助通风期间的一个基本问题是如何使通气节奏同步与患者的呼吸努力平稳，有效地同步。异议障碍可能导致呼吸的增加/浪费，患者不适，镇静的需求增加，气管造口术的率更高，机械通气的持续时间较长，无通气天数减少，更长的ICU和医院住院时间以及较低的生存可能性和存活率和出院的可能性。当前一代通风器要么完全使用重型镇静/肌肉瘫痪（基于呼吸机通风）完全决定呼吸节奏，要么让患者通过呼吸触发呼吸机的呼吸（基于患者的通风）。极端都不是最佳的。我们提出了下一代通气辅助（基于夹带的机械通气，EMV），该辅助基于耦合振荡器之间相互夹带的经典物理学理论，这可能为这一临床问题提供具有成本效益的解决方案。这种创新的技术是由我们最近发现的，即控制呼吸的大脑电路能够通过学习和记忆来进入呼吸机，并通过学习和记忆遗传释放呼吸器的通货膨胀反射反射。在EMV中，患者的赞助者呼吸节奏和呼吸机节奏在同一节奏上相互锁定，就像两个人一起跳舞。根据先前的NIH ARRA挑战率（RC1）奖，我们在广泛使用的机械通气（Puritan-Bennett Model 840）上实施了EMV的原型，并证明了这种新技术在计算机化的肺模拟器上的可行性。基于这些仿真结果，FDA最近授予了针对研究装置豁免的有条件批准，用于对EMV模式的初步临床研究。 To transition the base technology from the bench top to the bedside, a multidisciplinary research team completed of a basic researcher/bioengineer (Dr. Poon, PI), a clinical (Dr. Harris, Co-I), a biostatistician (Dr. Schoenfeld, statistical consultan) and a technology developer (Covidien/Puritan-Bennett) has been formed to address the underlying scientific, engineering, statistical and clinical问题。该试点Projet的目的是首先确定所提出的EMV模式在短时间（4小时）期间既安全又有效地吸引患者的呼吸节奏（AIM 1）。本I阶段临床研究将使我们能够微调EMV模式的参数，以进一步最大程度地降低风险并最大程度地提高EMV模式在长期改善患者 - 换胎同步方面的有效性。第二阶段（AIM 2）是确定EMV模式在患者的整个通风断奶期间使用时提供了改善ARDS患者的同步性的安全和可行。提出的II/II期研究既需要且足以确保FDA批准将来将在未来进行的全尺度III期多中心试验，以便测试在通风式焊接过程中是否会导致患者 - 易位者同步改善与EMV模式的同步。