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.

项目摘要 候选人：MSCI乔纳森·凯西（Jonathan Casey）博士是范德比尔特大学医学中心的助理教授。 凯西博士在通过正式培训中获得的重病成年人的临床试验中具有强大的背景 临床研究和呼吸支持比较有效性试验的进行。他的长期 作为医师科学家的职业计划将被公认为是进行务实试验的领导者 重病成年人的早期呼吸支持。为了实现这一目标，他的直接目标是适应务实 他在重症监护室中使用了紧急情况的混乱环境 部门，成为紧急研究中使用的同意形式的专家，获得应用的经验 实施科学的工具，以提高务实试验的质量，并学习高级建模 丰富临床试验和分析治疗效果的异质性所需的方法。 研究项目：每年超过150万重病患者接受机械通气 美国，以及危重患者机械通气的气管气管的放置是 充满并发症，患有五分之一的患有低氧血症和四分之一的心脏心脏 逮捕。袋掩蔽通风已显示可防止ICU患者中威胁生命的低氧血症， 但是目前尚不清楚这些结果是否概括为ED和院前环境 患者插管。由于患者人群的差异，ED中的患者平均在较低 塞脑周刊低氧血症和较高的攻击风险（拟议的袋掩蔽通风风险）和较高的风险 在这种情况下，很少使用Bagmask通风。提高了对行李的风险和益处的了解 - 急需迫切需要在ED中的气管插管期间的掩模通风。提议的具体目的 研究是：目标1）开发一个模型，以估计气管插管期间最低的氧饱和度 埃德; AIM 2）使用AIM 1中的模型进行预后富集，有选择地招募有风险的患者 在ED（安全性）研究中，低氧血症进入Bag掩蔽通风的安全性，这是一项464患者 随机试验测试袋掩蔽通风将增加最低的氧饱和度的假设 急诊科正在插管的患者。 职业发展：凯西博士的职业发展计划整合了课程工作，体验式学习和 与他的导师培训：1）学习开发和分析安全所需的建模技术 通风审判； 2）在紧急护理研究中开发具有EFIC和其他形式的同意的专业知识；和 3）利用实施科学的工具来改善务实试验期间的试验干预措施的交付。 环境：作为一个支持且资源良好的机构，国际领导人在临床试验中， 急诊研究，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 促进凯西博士发展成为早期呼吸支持试验的国家领导者的环境。