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.

项目摘要 候选人：乔纳森博士凯西医学博士，MSCI是范德比尔特大学医学中心的助理教授。 博士凯西有一个强大的背景，在临床试验的重症成人获得通过正规培训， 临床研究和进行呼吸支持的比较有效性试验。他的长期 作为一名医生科学家的职业计划是成为公认的进行务实试验的领导者 重症成人的早期呼吸支持。为了实现这一目标，他的近期目标是调整务实的 他曾在重症监护室的混乱环境中试用过这种方法 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 从实施科学的工具，提高务实的审判质量，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150多万重症患者在医院接受机械通气， 美国，并在危重患者中放置气管内导管进行机械通气， 充满了并发症，五分之一的人经历低氧血症，四十分之一的人经历心脏病 逮捕了袋式面罩通气已被证明可以预防ICU患者中危及生命的低氧血症， 但目前尚不清楚这些结果是否适用于艾德和院前环境，在这些环境中， 病人都被打了。由于患者人群的差异，艾德中的患者平均 插管周围低氧血症的风险和较高的吸入风险（袋式面罩通气的拟定风险），以及 在这种情况下很少使用袋式面罩通气。更好地了解袋的风险和益处- 艾德气管插管期间的面罩通气是迫切需要的。建议的具体目标 目的：1）建立一个模型来估计气管插管期间的最低血氧饱和度， 目标2）使用目标1的模型进行预后富集，选择性地招募风险患者 在艾德（SAFEVENTED）研究中，464名患者 一项随机试验，检验袋式面罩通气会增加患者最低氧饱和度的假设。 在急诊室接受插管的患者。 职业发展：凯西博士的职业发展计划整合了课程，体验式学习， 与他的导师一起培训：1）学习开发和分析SAFE所需的建模技术- VENTED试验; 2）发展EFIC和紧急护理研究中使用的其他同意形式的专业知识;以及 3)利用实施科学的工具，在务实的试验中改善试验干预措施的交付。 环境：作为一个支持性和资源充足的机构，在临床试验方面具有国际领先地位， 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 环境，以促进博士凯西的发展成为全国领先的试验早期呼吸支持。