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.

项目摘要/摘要