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.

项目摘要： 候选人：候选人，Sonal Pannu，医学博士是肺部的早期职业调查员， 重症监护和俄亥俄州立大学的睡眠医学，并具有出色的学术记录。她 已经表现出对提高机械安全性的临床和翻译研究的持续兴趣 通风，重点是预防高氧和缺氧。此外，她还开发了生物信息学 相关的电子算法，用于靶向氧合，并使用氧化脂肪组生物标志物来确定 最佳氧合靶标。她的短期目标是通过先进的 在务实和新型临床试验设计，生物信息学和相关统计数据中进行培训 脂肪组学生物标志物。她的长期目标是成为成功的独立临床和翻译 科学家领导一个多学科研究小组，专注于ICU的实用临床试验 脂质组生物标志物，用于确定最佳氧合，以改善重症患者的预后。 职业发展：Pannu博士的职业发展将包括参加正式培训的计划 务实的多中心临床试验；在脂肪组学中；在生物信息学和相关统计学中 和经验丰富的学习。环境：Pannu博士目前处于极为支持的环境中 她作为临床和翻译研究人员的发展。有大量的ICU患者人数 并支持用于临床研究，生物信息学，临床协调员和实验室的资源形式 技术人员。 Pannu'smentors博士，俄亥俄州立大学），Diaz（俄亥俄州立大学）和博士 赖斯（范德比尔特）作为导师的历史悠久，此外，她的研究咨询委员会还包括 资金丰富且有成就的研究人员。研究：Pannu博士在该项目中的目标是研究 通过自动氧滴定策略来实现靶向氧合目标的方法。她的具体目标 是：目标1：确定基于电子健康记录的氧气屈服策略的效率 维持经过验证，优化的靶向周围氧气安全范围的动脉氧气安全范围 和目标2：分析氧化的脂质生物标志物作为相关肺损伤的标志物 与通常的护理相比，具有优化靶向氧合策略的患者。完成 这位潘努博士将通过聚类随机进行务实的临床试验，阶梯楔 使用自动化协议与呼吸机的常规方法研究靶向氧合的设计 管理指南。她将评估短期（基于呼吸机和ICU）和长期临床结果 （认知功能评估6个月的随访）。她还将测量和比较氧化的脂质 两组内的生物标志物，以确定氧化的生物标志物谱以进行最佳氧合和 将它们的表达与氧气暴露和无呼吸机的日子相关联。