2/2: PREcision VENTilation to attenuate Ventilation-Induced Lung Injury (PREVENT VILI)

2/2：精确通气以减轻通气引起的肺损伤（预防 VILI）

基本信息

批准号：
10738959
负责人：
Elias Baedorf Kassis
金额：
$ 117.54万
依托单位：
BETH ISRAEL DEACONESS MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-01 至 2030-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10738959
关键词：
Acute Respiratory Distress Syndrome Address Admission activity Adult Adverse event Applications Grants Attenuated Automobile Driving Biological Markers Body Weight Breathing COVID-19 mortality COVID-19 pandemic Case Report Form Cause of Death Clinical Clinical Trials Data Monitoring Committees Collaborations Communication Consent Critical Illness Data Data Collection Data Coordinating Center Data Set Electronics Enrollment Ensure Feedback Fostering Funding Agency Goals Grant Healthcare Systems Infrastructure Injury Instruction Intervention Investigation Laboratories Lung Maintenance Manuscripts Measurement Measures Mechanical ventilation Methodology Monitor Morbidity - disease rate Newsletter Outcome Participant Patients Phase Physiological Population Positive-Pressure Respiration Preparation Prevention strategy Protocol Compliance Protocols documentation Quality Control Randomized, Controlled Trials Recording of previous events Recovery Reporting Reproducibility Research Research Personnel Respiratory Mechanics Risk Shock Site Stress Techniques Teleconferences Testing Tidal Volume Time Titrations Ventilator Ventilator-induced lung injury arm atelectrauma community engagement cost data management design efficacy testing electronic data capture system evidence base expiration hemodynamics high risk high standard improved innovation lung injury lung pressure meetings mortality novel patient oriented patient safety personalized approach personalized strategies pre-pandemic pressure prevent primary outcome prospective protocol development randomized trial respiratory safety assessment standard care standard of care statistical center support tools symposium treatment arm treatment as usual trial planning usual care arm ventilation web site

Acute Respiratory Distress Syndrome Address Admission activity Adult Adverse event Applications Grants Attenuated Automobile Driving Biological Markers Body Weight Breathing COVID-19 mortality COVID-19 pandemic Case Report Form Cause of Death Clinical Clinical Trials Data Monitoring Committees Collaborations Communication Consent Critical Illness Data Data Collection Data Coordinating Center Data Set Electronics Enrollment Ensure Feedback Fostering Funding Agency Goals Grant Healthcare Systems Infrastructure Injury Instruction Intervention Investigation Laboratories Lung Maintenance Manuscripts Measurement Measures Mechanical ventilation Methodology Monitor Morbidity - disease rate Newsletter Outcome Participant Patients Phase Physiological Population Positive-Pressure Respiration Preparation Prevention strategy Protocol Compliance Protocols documentation Quality Control Randomized, Controlled Trials Recording of previous events Recovery Reporting Reproducibility Research Research Personnel Respiratory Mechanics Risk Shock Site Stress Techniques Teleconferences Testing Tidal Volume Time Titrations Ventilator Ventilator-induced lung injury arm atelectrauma community engagement cost data management design efficacy testing electronic data capture system evidence base expiration hemodynamics high risk high standard improved innovation lung injury lung pressure meetings mortality novel patient oriented patient safety personalized approach personalized strategies pre-pandemic pressure prevent primary outcome prospective protocol development randomized trial respiratory safety assessment standard care standard of care statistical center support tools symposium treatment arm treatment as usual trial planning usual care arm ventilation web site

展开

项目摘要

PROJECT SUMMARY / ABSTRACT Acute respiratory distress syndrome (ARDS) occurs in up to one-quarter of all critically ill adults receiving mechanical ventilation and is associated with high risk of morbidity and mortality, which is compounded by ventilation-induced lung injury (VILI). Current ventilation strategies and standard care attempt to lessen the effects of VILI, but have not been uniformly successful. The need for improved ventilation strategies have become more compelling and urgent in the context of the COVID-19 pandemic. Precise ventilator titration of tidal volumes to maintain driving pressure ≤ 12 cm H2O may improve overdistension injury and application of positive end expiratory pressure (PEEP) with titration to transpulmonary pressure of 0±2cmH2O may prevent injury from lung collapse. This U24 grant application will establish a Data Coordinating Center (DCC) that supports the PREcision VENTilation to attenuate VILI Clinical Coordinating Center (CCC) in conducting a multicenter, prospective phase III randomized trial to test the hypothesis that this precision ventilation strategy will improve 60-day mortality compared to guided usual care in patients with moderate or severe ARDS. The DCC will provide the infrastructure, support, oversight and quality control necessary to conduct this trial guided by the following aims: Aim 1 - To collaborate in the protocol development. The DCC will assist the CCC in defining the overarching plan of the trial, and ensure the inclusion of essential sections within the protocol document. Aim 2 - To design and execute an appropriate, pre-determined, innovative statistical plan including analysis of study data, assessment of safety, investigation of mechanism of benefit, and facilitation of manuscript preparation. Aim 3 – To facilitate a patient centered study, with community engagement, by providing video-assisted consent materials, real-time reporting of accrual rates, with emphasis on ensuring a diverse participant population and ensuring patient safety by providing clear instructions on identification and timing of adverse event reporting and creation of the Data and Safety Monitoring Board. Aim 4 - To support an advanced physiological core laboratory to integrate physiological expertise into trial conduct and data management and to ensure rigor and reproducibility of respiratory waveform interpretation used for protocol-directed ventilator management in the intervention arm. The DCC will review all physiological waveforms submitted by sites and provide feedback regarding quality and interpretation. Aim 5 - To provide data administration and monitor trial activities. The DCC will build the eCRFs on a state-of-the-art electronic data capture system. During enrollment, the DCC will ensure high-quality data collection and measure and improve protocol compliance. To foster site communication and identity, the DCC will develop a trial website and quarterly newsletter, and assist the CCC in organizing meetings and conference calls. Aim 6 - To ensure completeness of the study and post-trial activities. This includes meeting milestones and end-of-trial support for participating sites and providing the funding agency with a finalized, deidentified, and locked data set for public use.

项目摘要 /摘要急性呼吸窘迫综合征（ARDS）发生在所有危重的成年人中最多四分之一机械通气，与发病和死亡率的高风险有关，这是由通风引起的肺损伤（VILI）。当前的通风策略和标准护理尝试减少 Vili的影响，但并非统一成功。需要改善通风策略的需求在Covid-19-19大流行的背景下变得更加引人注目和紧迫。潮汐的精确通气滴定维持驾驶压力≤12cm H2O的量可能会改善过度损伤和阳性的应用末端呼气压力（PEEP），滴定到0±2cmH2O的转肺压力可能会防止因受伤肺塌陷。该U24赠款应用程序将建立一个支持支持该中心的数据协调中心（DCC）精确通气以衰减VILI临床协调中心（CCC）进行多中心，前瞻性III期随机试验，以检验这种精确通气策略的假设与中度或重度ARD的患者进行指导的常规护理相比，死亡率为60天。 DCC将提供在以下方面进行此试验所必需的基础设施，支持，监督和质量控制目的：目标1-在协议开发中进行协作。 DCC将协助CCC定义审判的总体计划，并确保在协议文档中包含基本部分。目标2 - 设计和执行适当的，预先确定的创新统计计划，包括研究分析数据，安全性的评估，福利机制的投资以及手稿准备的设施。目标3 - 通过提供视频辅助同意，通过社区参与来促进以患者为中心的研究材料，重音率的实时报告，重点是确保潜水员参与者和通过提供有关不良事件报告的身份证明和时间的明确说明，确保患者的安全创建数据和安全监控板。目标4-支持先进的物理核心实验室将物理专业知识纳入试验和数据管理，并确保严格用于协议定向呼吸机管理的呼吸波形解释的可重复性干预臂。 DCC将审查站点提交的所有物理波形并提供反馈关于质量和解释。目标5-提供数据管理和监视试验活动。 DCC 将在最先进的电子数据捕获系统上构建ECRF。在入学期间，DCC将确保高质量的数据收集和测量并提高协议合规性。促进网站通信和身份，DCC将开发一个试用网站和季度新闻通讯，并协助CCC组织会议和电话会议。目标6-确保研究和审前活动的完整性。这包括开会对参与站点的里程碑和审判终结支持，并为资助机构提供最终确定的去识别并锁定数据集，以供公众使用。