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.

项目总结/摘要 急性呼吸窘迫综合征（ARDS）发生在所有重症成人中的四分之一， 机械通气并与高发病率和死亡率风险相关， 通气诱导性肺损伤（VILI）。目前的通气策略和标准护理试图减少 的影响，但并没有取得一致的成功。对改进通风策略的需求 在COVID-19大流行的背景下变得更加紧迫和紧迫。精密呼吸机滴定潮气量 维持驱动压≤ 12 cm H2O的容量可改善过度扩张损伤， 呼气末压力（PEEP）滴定至0± 2cmH 2 O的跨肺压可防止 肺萎陷该U24资助申请将建立一个数据协调中心（DCC）， PRECISION VENTILATION，以减轻VILI临床协调中心（CCC）在进行多中心， 一项前瞻性III期随机试验，旨在检验这种精确通气策略将改善 60-中度或重度ARDS患者的日死亡率与指导性常规护理的比较。DCC将提供 在以下指导下开展本试验所需的基础设施、支持、监督和质量控制 目标：目标1 -在议定书的制定方面进行合作。发展协调委员会将协助协调委员会确定 试验的总体计划，并确保方案文件中包含重要部分。目的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、获益机制研究和促进手稿准备。 目标3 -通过提供视频辅助同意，促进以患者为中心的研究，并与社区合作 应计比率的实时报告，重点是确保参与人的多样性， 通过提供关于不良事件报告的识别和时间的明确说明，确保患者安全， 建立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，并确保严格性和 用于方案指导的呼吸机管理的呼吸波形解释的重现性 DCC将审查研究中心提交的所有生理波形，并提供反馈 关于质量和解释。目的5 -提供数据管理和监测试验活动。的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 高质量数据收集和衡量以及改进对议定书的遵守。促进现场沟通， 为了加强协调委员会的身份，协调委员会将建立一个试验网站和季度通讯，并协助协调委员会组织会议 和电话会议。目标6 -确保研究和试验后活动的完整性。其中包括会议 为参与研究中心提供里程碑和试验结束支持，并向资助机构提供最终的， 去身份化和锁定数据集供公众使用。