Bag-Mask Ventilation to PreVent Hypoxemia during Tracheal Intubation in the Emergency Department: A Clinical Trial

急诊科气管插管期间使用面罩通气预防低氧血症：临床试验

• 批准号: 10038068
• 负责人: Jonathan Dale Casey
• 金额: $ 18.15万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-01 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10038068
• 关键词: Academic Medical Centers; Accident and Emergency department; Active Learning; Address; Adult; Adult Respiratory Distress Syndrome; Adverse event; Affect; Anesthesia procedures; Award; Benefits and Risks; Bioinformatics; Biometry; Calibration; Caring; Characteristics; Clinical; Clinical Research; Clinical Trials; Complication; Consent Forms; Critical Illness; Data; Databases; Development; Development Plans; Devices; Emergency research; Enrollment; Environment; Fasting; Fostering; Functional disorder; Funding; Future; Goals; Heart Arrest; Heterogeneity; Hypoxemia; Incidence; Inflammatory; Informed Consent; Institution; Insufflation; Intensive Care Units; International; Intervention; Intervention Trial; Intratracheal Intubation; Intubation; Journals; K-Series Research Career Programs; Knowledge; Laryngoscopy; Learning; Life; Linear Models; Lung; Maintenance; Manuals; Masks; Mechanical ventilation; Medicine; Mentors; Methodology; Methods; Modeling; Multicenter Trials; New England; Outcome; Oxygen; Oxygen Therapy Care; Patient-Focused Outcomes; Patients; Phase; Physicians; Pre-hospital setting; Publishing; Research; Research Project Grants; Resources; Respiratory Failure; Risk; Safety; Scientist; Statistical Methods; Stomach; Techniques; Testing; Time; Training; Tube; United States; United States National Institutes of Health; Weaning; career; career development; clinical trial analysis; comparative effectiveness trial; design; endotracheal; experience; high risk; human subject protection; implementation science; improved; lung injury; patient population; patient safety; pragmatic trial; predictive modeling; prevent; professor; prognostic; randomized trial; respiratory; risk benefit ratio; tool; treatment as usual; treatment effect; ventilation

PROJECT SUMMARY Candidate: Dr. Jonathan Casey MD, MSCI is an Assistant Professor at Vanderbilt University Medical Center. Dr. Casey has a strong background in clinical trials of critically ill adults obtained through formal training in clinical research and the conduct of comparative effectiveness trials of respiratory support. His long-term career plan as a physician scientist is to become recognized as a leader in the conduct of pragmatic trials of early respiratory support in critically ill adults. To achieve this, his immediate goals are to adapt the pragmatic trial methodology he has used in the intensive care unit to the chaotic environment of the emergency department, become an expert in the forms of consent used in emergency research, gain experience applying tools from implementation science to improve the quality of pragmatic trials, and learn the advanced modeling methods required for enriching clinical trials and analyzing of heterogeneity of treatment effect. Research Project: Each year more than 1.5 million critically ill patients receive mechanical ventilation in the United States, and the placement of an endotracheal tube for mechanical ventilation in critically ill patients is fraught with complications with one-in-five experiencing hypoxemia and one-in-forty experiencing cardiac arrest. Bag-mask ventilation has been shown to prevent life-threatening hypoxemia among patients in the ICU, but it is unclear if these results generalize to the ED and pre-hospital setting, where the majority of critically patients are intubated. Due to differences in patient populations, patients in the ED are, on average, at lower risk for peri-intubation hypoxemia and higher risk of aspiration (a proposed risk of bag-mask ventilation), and bag-mask ventilation is rarely used in this setting. Improved understanding of the risks and benefits of bag- mask ventilation during tracheal intubation in the ED is urgently needed. The Specific Aims of the proposed research are: Aim 1) Develop a model to estimate the lowest oxygen saturation during tracheal intubation in the ED; and Aim 2) Use the model from Aim 1 for prognostic enrichment, selectively enrolling patients at risk for hypoxemia into the SAFEty of bag-mask VENTilation in the ED (SAFEVENTED) study, a 464-patient randomized trial testing the hypothesis that bag-mask ventilation will increase the lowest oxygen saturation of patients undergoing intubation in the emergency department. Career Development: Dr. Casey's career development plan integrates coursework, experiential learning, and training with his mentors to: 1) learn the modeling techniques required to develop and analyze the SAFE- VENTED trial; 2) develop expertise in EFIC and other forms of consent used in emergency care research; and 3) leverage tools from implementation science to improve delivery of trial interventions during pragmatic trials. Environment: As a supportive and well-resourced institution with international leaders in clinical trials, emergency care research, human subjects protection, bioinformatics, and biostatistics, Vanderbilt is the ideal environment to foster Dr. Casey's development into a national leader in trials of early respiratory support.

项目概要 候选人：Jonathan Casey 博士，医学博士，MSCI，范德比尔特大学医学中心助理教授。 Casey 博士通过正规培训获得了重症成人临床试验的丰富背景。 进行呼吸支持的临床研究和比较有效性试验。他的长期 作为一名医师科学家的职业规划是成为公认的进行实用试验的领导者 危重成人的早期呼吸支持。为了实现这一目标，他的近期目标是适应务实的 他在重症监护室对紧急情况的混乱环境使用过的试验方法 部门，成为紧急研究中使用的同意形式的专家，获得应用经验 来自实施科学的工具可提高实用试验的质量，并学习先进的建模 丰富临床试验和分析治疗效果异质性所需的方法。 研究项目：每年有超过150万重症患者在医院接受机械通气 美国，对重症患者放置气管插管进行机械通气 充满并发症，五分之一的人经历过低氧血症，四分之一的人经历过心脏病 逮捕。袋式面罩通气已被证明可以预防 ICU 患者危及生命的低氧血症， 但尚不清楚这些结果是否适用于急诊室和院前环境，因为大多数重症患者 患者正在插管。由于患者群体的差异，急诊科患者的平均水平较低 围插管期间低氧血症的风险和较高的误吸风险（建议使用球囊面罩通气的风险），以及 在这种情况下很少使用球囊面罩通气。更好地了解袋子的风险和好处 急诊科气管插管期间迫切需要面罩通气。拟议的具体目标 研究的目标是： 目标 1) 开发一个模型来估计气管插管期间的最低氧饱和度 急诊室；目标 2) 使用目标 1 中的模型进行预后丰富，有选择地招募有风险的患者 在 ED (SAFEVENTED) 研究中，针对低氧血症纳入气囊面罩通气的安全性，该研究涉及 464 名患者 随机试验检验袋式面罩通气将增加患者最低氧饱和度的假设 在急诊科接受插管的患者。 职业发展：凯西博士的职业发展计划整合了课程作业、体验式学习和 与导师一起进行培训：1）学习开发和分析 SAFE- 所需的建模技术 通风试验； 2) 发展紧急护理研究中使用的 EFIC 和其他形式同意的专业知识；和 3) 利用实施科学的工具来改善实用试验期间试验干预的实施。 环境：作为一家支持性且资源丰富的机构，在临床试验方面拥有国际领先地位， 紧急护理研究、人类受试者保护、生物信息学和生物统计学，范德比尔特是理想的选择 培养凯西博士发展成为早期呼吸支持试验的全国领导者的环境。