Leveraging Automated Optimization of Inspired Oxygen and Oxidized Biomarker Lipidomics for Targeted Oxygenation during Mechanical Ventilation: a Pragmatic Clinical Trial

利用吸入氧和氧化生物标志物脂质组学的自动优化在机械通气期间进行靶向氧合：一项实用的临床试验

• 批准号: 10592000
• 负责人: Sonal R. Pannu
• 金额: $ 17.02万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-19 至 2027-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10592000
• 关键词: Active Learning; Acute Lung Injury; Adverse effects; Advisory Committees; Affect; Algorithms; Automobile Driving; Bioinformatics; Biological Markers; Bronchoalveolar Lavage Fluid; Clinical; Clinical Research; Clinical Trials Design; Cluster randomized trial; Cognitive; Coupled; Critical Care; Critical Illness; Data; Development; Doctor of Medicine; Electronic Health Record; Electronics; Enrollment; Ensure; Environment; Event; Exclusion; Exposure to; Funding; Future; Goals; Guidelines; Health Personnel; Hour; Hyperoxia; Hypoxemia; Hypoxemic Respiratory Failure; Hypoxia; Injury; Interdisciplinary Study; Intervention; Knowledge; Laboratory Technicians; Length of Stay; Life; Lipid Peroxidation; Lipids; Lung; Mass Spectrum Analysis; Measures; Mechanical ventilation; Mediating; Medicine; Mentors; Metabolic acidosis; Multi-Institutional Clinical Trial; Ohio; Omega-3 Fatty Acids; Organ failure; Outcome; Oxidative Stress Induction; Oxygen; Oxygen Therapy Care; Patient-Focused Outcomes; Patients; Peripheral; Persons; Physicians; Physiological; Pilot Projects; Population; Pragmatic clinical trial; Prevention; Protocols documentation; Quality of life; Questionnaires; Randomized; Recording of previous events; Research; Research Personnel; Resources; Respiratory Failure; Rice; Safety; Scientist; Sleep; Sonal; Supplementation; Survivors; Telephone; Therapeutic; Time; Tissue Preservation; Tissues; Titrations; Toxic effect; Training; Translational Research; Universities; Unsaturated Fatty Acids; Variant; Ventilator; biomarker identification; cardiovascular collapse; career; career development; cell injury; cognitive function; design; efficacy evaluation; follow-up; hyperoxia induced lung injury; improved; improved outcome; innovation; interest; lipidomics; lung failure; lung injury; mortality; novel; oxidized lipid; oxygen toxicity; patient population; peroxidation; prevent; primary outcome; secondary outcome; skills; statistics; supplemental oxygen; tissue oxygenation; tool; translational approach; translational scientist; treatment as usual

PROJECT SUMMARY: Candidate: The candidate, Sonal Pannu, M.D. is an early career investigator from the division of Pulmonary, Critical Care, and Sleep Medicine at the Ohio State University and has an excellent academic track record. She has demonstrated persistent interest in clinical and translational research for improving the safety of mechanical ventilation, focusing on prevention of hyperoxia and hypoxemia. In addition, she has developed bioinformatics related electronic algorithms for targeted oxygenation and is using oxidized lipidomics biomarkers to determine optimal oxygenation targets. Her short-term goal is to augment the clinical researchtraining with advanced training in pragmatic and novel clinical trial design, bioinformatics and associated statistics for development of lipidomics biomarkers. Her long term goal is to become a successful independent clinical and translational scientist leading a multidisciplinary research team focused on pragmatic clinical trials in the ICU for utilizing lipidomics biomarkers for ascertainment of optimal oxygenation to improve outcomes of critically ill patients. Career Development: Dr. Pannu’s career development will include plans enroll in formal training for conducting pragmatic multi-center clinical trials; in lipidomics; in bioinformatics and associated statistics through didactics and experiential learning. Environment: Dr. Pannu is currently in an environment that is extremely supportive for her development as a clinical and translational researcher. There is a large ICU patient population and support in the form of resources for clinical research, bioinformatics, clinical coordinators and laboratory technicians. Dr. Pannu’smentors, Dr. Crouser (Ohio State University), Dr. Diaz (Ohio State University) and Dr. Rice (Vanderbilt) have an outstanding history as mentors in addition her research advisory committee consists of well-funded and accomplished researchers. Research: Dr. Pannu’s goal in this project is to study an approach to targeted oxygenation goals through an automated oxygen titration strategy. Her specific aims are: Aim 1: Determine the efficacy of an electronic health record based oxygen-titration strategy to maintain arterial oxygen saturation validated, optimized targeted peripheral oxygen saturation range and Aim 2: Analyze oxidized lipid biomarkers as markers of hyperoxia associated lung injury in patients with the optimized targeted oxygenation strategy compared with usual care. To accomplish this Dr. Pannu will conduct a pragmatic clinical trial with cluster randomization, stepped wedge design to study targeted oxygenation with an automated protocol vs conventional approach by ventilator management guidelines. She will assess short term (ventilator and ICU based) and long term clinical outcomes (6 month follow up for cognitive function assessment). She will also measure and compare oxidized lipid biomarkers within the two groups to determine the oxidized biomarker profile for optimal oxygenation and correlate their expression to the degree ofoxygen exposure and ventilator-free days.

项目概要： 候选人：候选人，Sonal Pannu，医学博士。是肺科的早期职业调查员 重症监护和睡眠医学在俄亥俄州州立大学，并有一个良好的学术记录。她 已经表现出对临床和转化研究的持续兴趣，以提高机械安全性， 通气，重点预防高氧和低氧血症。此外，她还开发了生物信息学 相关的电子算法的靶向氧合，并使用氧化脂质组学生物标志物，以确定 最佳氧合目标。她的短期目标是用先进的 培训实用和新颖的临床试验设计，生物信息学和相关统计学，以开发 脂质组学生物标志物。她的长期目标是成为一个成功的独立的临床和翻译 一位科学家领导一个多学科研究小组，专注于在ICU进行实用的临床试验， 脂质组学生物标志物用于确定最佳氧合，以改善危重患者的结局。 职业发展：Pannu博士的职业发展将包括参加正式培训， 实用的多中心临床试验;在脂质组学;在生物信息学和相关统计学通过教学法 和体验式学习。环境：Pannu博士目前处于非常支持的环境中 作为一名临床和翻译研究人员的发展。ICU患者人数众多 并以临床研究、生物信息学、临床协调员和实验室资源的形式提供支持 专业人帕努博士的导师，克劳泽博士（俄亥俄州州立大学），迪亚兹博士（俄亥俄州州立大学）和博士。 赖斯（范德比尔特）有一个杰出的历史，除了她的研究顾问委员会组成的导师 资金充足且有成就的研究人员研究：Pannu博士在这个项目中的目标是研究 通过自动氧滴定策略实现目标氧合目标的方法。她的具体目标 目标1：确定基于电子健康记录的氧滴定策略的功效， 维持经验证的动脉血氧饱和度，优化目标外周血氧饱和度范围 目的2：分析氧化脂质生物标志物作为高氧相关肺损伤的标志物， 与常规护理相比，优化靶向氧合策略的患者。完成 这位Pannu博士将进行一项实用的临床试验， 旨在研究自动化方案与呼吸机常规方法的靶向氧合 管理方针。她将评估短期（基于呼吸机和ICU）和长期临床结局 （6个月随访进行认知功能评估）。她还将测量和比较氧化脂质 两组内的生物标志物，以确定最佳氧合的氧化生物标志物谱， 将它们的表达与氧暴露程度和无呼吸机天数相关。