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: 10226254
• 负责人: Jonathan Dale Casey
• 金额: $ 18.42万
• 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/10226254
• 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; efficacy outcomes; endotracheal; experience; high risk; human subject protection; implementation science; implementation tool; improved; lung injury; patient population; patient safety; pragmatic trial; prevent; professor; prognostic; prognostic model; 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.

项目总结 候选人：乔纳森·凯西博士，MSCI医学博士，范德堡大学医学中心助理教授。 凯西博士在通过正规培训获得的危重成人临床试验方面有很强的背景 进行呼吸支持的临床研究和有效性比较试验。他的长期 作为一名内科科学家的职业规划将成为进行务实试验的领导者 危重成人的早期呼吸支持。为了实现这一目标，他的直接目标是调整务实的 他曾在重症监护室使用的试验方法来应对混乱的急诊环境 部门，成为紧急研究中使用的同意书形式的专家，获得应用经验 从实施科学的工具来提高务实试验的质量，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150万名危重病人接受机械通气。 在危重病人中放置气管内插管用于机械通气是 充满并发症，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。袋式面罩通风已被证明可以预防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急诊室和院前环境，在这些环境中，大多数危重患者 病人被插管。由于患者群体的差异，急诊科患者的平均比例较低 插管周围低氧血症的风险和更高的吸入风险(袋式面罩通风的拟议风险)，以及 在这种情况下，袋式通风很少使用。提高了对袋子的风险和好处的理解- 急诊室迫切需要在气管插管时使用面罩。建议的具体目标 研究内容如下：目的1)建立一种模型，用于估计老年人气管插管时的最低血氧饱和度 ED；和Aim 2)使用Aim 1中的模型来丰富预后，有选择地招募有风险的患者 ED(SAFEVENTED)研究中低氧血症进入袋式面罩呼吸的安全性：一项464例患者的研究 袋式面罩通风可提高最低血氧饱和度假说的随机试验 在急诊科接受插管的病人。 职业发展：凯西博士的职业发展计划将课程学习、体验式学习和 与他的导师一起培训：1)学习开发和分析保险箱所需的建模技术- 排泄式试验；2)发展在紧急护理研究中使用的EFIC和其他形式的同意方面的专业知识；以及 3)利用实施科学的工具，在务实试验期间改进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，在临床试验方面处于国际领先地位， 急诊护理研究、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 环境，以促进Casey博士发展成为早期呼吸支持试验的国家领导者。