Optimizing Selection and Management of Cardiac Arrest Patients Treated with ECMO

优化接受 ECMO 治疗的心脏骤停患者的选择和管理

• 批准号: 9921472
• 负责人: Joseph Edward Tonna
• 金额: $ 18.9万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-06-15 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9921472
• 关键词: Accident and Emergency department; Address; Adult; Age; Attention; Blood; Brain; Cannulas; Cardiac; Cardiopulmonary Resuscitation; Case Series; Characteristics; Clinical Research; Clinical Trials; Communities; Conduct Clinical Trials; Consent; Data; Data Set; Databases; Diagnosis; Elements; Emergency Department Physician; Emergency Medicine; Enrollment; Ensure; Epidemiologist; Ethics; Extracorporeal Membrane Oxygenation; Funding; Future; Goals; Heart Arrest; Heterogeneity; Home environment; Hospitals; Hour; Informed Consent; Interview; Knowledge; Learning; Link; Medical; Mentored Patient-Oriented Research Career Development Award; Mentors; Methodology; Multi-Institutional Clinical Trial; Multicenter Trials; Neurologic; Outcome Study; Pathway interactions; Patient Selection; Patients; Physicians; Practice Management; Principal Investigator; Process; Protocols documentation; Research; Research Ethics; Research Personnel; Resuscitation; Selection Criteria; Site; Statistical Models; Surveys; Temperature; Testing; Time; Training; United States; Universities; Utah; Validation; Variant; career; career development; clinical practice; design; evidence base; implementation strategy; improved; mortality; novel; out-of-hospital cardiac arrest; patient oriented; patient population; preference; prospective; randomized trial; response; targeted treatment; trial design; uptake

PROJECT SUMMARY/ABSTRACT This is an application for a K23 award for Dr. Joseph Tonna, an emergency medicine trained intensivist at the University of Utah. Dr. Tonna is establishing himself as a young investigator in patient-oriented clinical research in the application and validation of rescue therapies such as extracorporeal membrane oxygenation (ECMO). This K23 award will provide Dr. Tonna with the support necessary to accomplish the following goals: (1) to develop expertise in survey design and qualitative assessment to support clinical trials, (2) develop expertise in community engagement and research ethics to improve the conduct and design of clinical research, (3) to develop expertise in the design and implementation multi-center clinical trials, and (4) to develop an independent clinical research career. To achieve these goals, Dr. Tonna has assembled a mentoring team comprising a primary mentor, Dr. Heather Keenan, an intensivist and epidemiologist who has performed large prospective outcome studies, and two co-mentors: Dr. Lance Becker, an emergency physician and recognized leader in cardiac arrest research, and Dr. Jeffrey Botkin, an expert in research ethics and community engagement. Dr. Tonna also has four advisors with expertise in clinical trials, ECMO, qualitative assessments, survey design and community engagement. The main therapy of cardiac arrest resuscitation is cardiopulmonary resuscitation (CPR), which has limited efficacy. As many as 88% of patients in cardiac arrest die. Dr. Tonna’s research prepares for clinical trials of a promising novel treatment in which ECMO is started during CPR (called extracorporeal CPR/eCPR). Dr. Tonna will (Aim 1) characterize patient selection criteria and management practices for eCPR that are associated with neurologically intact survival; (Aim 2) generate eCPR trial design selection criteria and management acceptable to physicians; (Aim 3) determine trial design and protocol features for eCPR trials conducted with an exception from informed consent that are acceptable to diverse communities. In Aim 1, Dr. Tonna will analyze a national eCPR dataset, learning advanced statistical modeling. Findings will inform optimal design of eCPR trials. In Aim 2, Dr. Tonna will interview practicing physicians to generate and administer a national survey to determine the acceptability of eCPR trial elements. In Aim 3, Dr. Tonna will perform community engagement to generate design and implementation strategies for future eCPR trials conducted using exception from informed consent. Results of SA2 and SA3 will inform eCPR trials that are acceptable to physicians and to diverse communities. This research will prepare Dr. Tonna to design and implement scientifically rigorous and ethical eCPR trials.

项目总结/摘要 这是一份K23奖的申请，申请者是约瑟夫·托纳博士，他是一名急诊医学专业的重症监护医生， 犹他州大学。Tonna博士正在建立自己作为一个年轻的研究者在以病人为导向的临床 研究急救疗法的应用和验证，如体外膜肺氧合 （ECMO）。该K23奖项将为Tonna博士提供必要的支持，以实现以下目标： (1)发展调查设计和定性评估方面的专业知识，以支持临床试验，（2）发展 社区参与和研究伦理方面的专业知识，以改善临床研究的开展和设计。 研究，（3）开发设计和实施多中心临床试验的专业知识，以及（4） 发展独立的临床研究事业。为了实现这些目标，托纳博士组建了一个 指导团队由主要导师石楠基南博士组成，他是一名重症监护医师和流行病学家， 进行了大量的前瞻性结果研究，两位共同导师：急诊医生兰斯·贝克尔博士 心脏骤停研究领域公认的领导者，以及研究伦理学专家杰弗里·博特金博士， 社区参与。Tonna博士还有四名顾问，他们在临床试验、ECMO、定性和定量方面都有专业知识。 评估、调查设计和社区参与。 心脏骤停复苏的主要治疗方法是心肺复苏（CPR）， 功效多达88%的心脏骤停患者死亡。Tonna博士的研究为临床试验做准备， 有前途的新治疗，其中ECMO在CPR期间启动（称为体外CPR/eCPR）。唐娜医生 将（目标1）描述与以下相关的eCPR患者选择标准和管理实践： 神经系统完整生存期;（目标2）制定eCPR试验设计选择标准和管理 （目标3）确定采用以下方法进行的eCPR试验的试验设计和方案特征： 这是知情同意的例外，是不同社区可以接受的。在目标1中，Tonna博士将 分析国家eCPR数据集，学习先进的统计建模。研究结果将为优化设计提供信息， eCPR试验。在目标2中，Tonna博士将采访执业医生，以制定和管理一个全国性的 调查以确定eCPR试验要素的可接受性。在目标3中，Tonna博士将执行社区 参与制定未来eCPR试验的设计和实施策略， 知情同意例外。SA 2和SA 3的结果将为eCPR试验提供信息， 医生和不同的社区。这项研究将为Tonna博士的设计和实施做好准备 科学严谨和道德的eCPR试验。