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

基本信息

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
项目类别：
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

项目摘要

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（由申请人证明）：ICU辅助通风期间的一个基本问题是对Patieng呼吸的全部疗程如何平稳而有效生存的概率和家居的镇静 /肌肉瘫痪（基于呼吸机的通风），或者让患者通过呼吸触发呼吸器的呼吸（基于患者的通风）。基于夹带的机械通气，EMV）基于双方振荡器之间相互夹带的理论，这是我们恢复的动机。反射。基于这些模拟结果，FDA对研究豁免的有条件批准是对EMV模式的初步临床研究的批准。 Harris，Co-i），生物统计学家（Schoenfeld博士，统计咨询师）和技术开发人员（COVIDIENT/PURITAN-BENNETT），以解决基本的科学，工程，统计和临床问题。提出的EMV模式既是终止患者的呼吸（4小时）时期（AIM 1）。 EMV在很长一段时间内改善patintilator nChrony（AIM 2）是确定EMV在提供ARDS患者通风术中的改进的同步性方面是安全且可行的。 FDA批准了将来将在未来进行的全面III阶段多中心试验，以测试在R闭合过程中使用EMV模式材料的提高Patilator，以便在R Oncenening期间获得材料有益的结果。