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）

• 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
• 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

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.

项目概要/摘要 接受治疗的所有危重成人中，多达四分之一发生急性呼吸窘迫综合征 (ARDS) 机械通气与发病率和死亡率的高风险相关，再加上 通气引起的肺损伤（VILI）。当前的通气策略和标准护理试图减少 VILI 的效果，但尚未一致成功。需要改进通风策略 在 COVID-19 大流行的背景下变得更加引人注目和紧迫。精确的呼吸机潮汐滴定 维持驱动压≤ 12 cm H2O 的容量可能会改善过度膨胀损伤并应用正压 呼气末压 (PEEP) 滴定至跨肺压 0±2cmH2O 可预防因以下原因造成的损伤： 肺萎陷。这项 U24 拨款申请将建立一个数据协调中心 (DCC)，以支持 PREcision VENTilation 旨在削弱 VILI 临床协调中心 (CCC) 开展多中心、 前瞻性 III 期随机试验，检验这种精确通气策略将改善的假设 中度或重度 ARDS 患者的 60 天死亡率与指导常规护理相比。 DCC 将提供 进行本试验所需的基础设施、支持、监督和质量控制，遵循以下原则 目标： 目标 1 - 合作开发协议。 DCC 将协助 CCC 定义 试验的总体计划，并确保将重要部分纳入方案文件中。目标2 - 设计和执行适当的、预先确定的、创新的统计计划，包括研究分析 数据、安全性评估、效益机制研究以及促进稿件准备。 目标 3 – 通过提供视频辅助同意书，促进以患者为中心的研究、社区参与 材料、应计率的实时报告，重点是确保参与者群体的多样化和 通过提供有关不良事件报告的识别和时间安排的明确说明来确保患者安全 创建数据和安全监测委员会。目标 4 - 支持先进的生理学核心实验室 将生理学专业知识整合到试验实施和数据管理中，并确保严谨和 用于方案指导呼吸机管理的呼吸波形解释的可重复性 干预臂。 DCC将审核站点提交的所有生理波形并提供反馈 关于质量和解释。目标 5 - 提供数据管理并监控试验活动。 DCC 将在最先进的电子数据采集系统上构建 eCRF。在注册期间，DCC 将确保 高质量的数据收集和测量并提高协议合规性。为了促进现场沟通和 身份，DCC将开发试用网站和季刊通讯，并协助CCC组织会议 和电话会议。目标 6 - 确保研究和试验后活动的完整性。这包括会议 为参与站点提供里程碑和试验结束支持，并向资助机构提供最终确定的、 去识别化和锁定的数据集供公众使用。