Optimizing Tracheal Intubation Outcomes and Neonatal Safety (OPTION SAFE)

优化气管插管结果和新生儿安全（OPTION SAFE）

• 批准号: 10518807
• 负责人: Elizabeth Foglia
• 金额: $ 72.9万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10518807
• 关键词: Accounting; Address; Adverse event; Caring; Child; Childhood; Clinical; Cluster randomized trial; Competence; Critical Illness; Educational Status; Educational workshop; Effectiveness; Emergency Situation; Ensure; Equipment; Event; Failure; Funding; Goals; Hospitals; Incidence; Individual; Infant; Infrastructure; Institution; Intention; Intervention; Intratracheal Intubation; Intubation; Laryngoscopes; Laryngoscopy; Learning; Life; Mechanical ventilation; Methodology; Modification; Morbidity - disease rate; Multi-Institutional Clinical Trial; National Institute of Child Health and Human Development; Neonatal; Neonatal Intensive Care; Neonatal Intensive Care Units; Outcome; Oxygen; Paralysed; Patient Rights; Patient risk; Patient-Focused Outcomes; Patients; Premature Infant; Premedication; Procedures; Provider; Randomized; Recommendation; Registries; Research; Resuscitation; Risk; Risk Assessment; Safety; Savings; Site; Testing; Time; Update; base; effectiveness evaluation; evidence base; experience; high risk; improved; intraventricular hemorrhage; mortality; neonatal patient; neonate; patient safety; personalized approach; post intervention; practice factors; primary outcome; prospective; prototype; safety outcomes; secondary outcome; skills; success; tool; treatment effect; uptake; ventilation

PROJECT SUMMARY Tracheal Intubation (TI) is a common life-saving intervention for resuscitation of critically ill infants in Neonatal Intensive Care Units (NICUs). Through our NICHD-funded NICU multicenter registry (National Emergency Airway Registry for Neonates: NEAR4NEOS), we have identified that Adverse TI Associated Events (TIAEs) occur in 22% TIs, severe TIAES occur in 4% TIs, and multiple attempts occur in 23% TIs. Oxygen desaturations (captured separately from TIAEs) are frequent and pronounced, with a mean 28% decline in SpO2 during neonatal TI. Moreover, neonates who experienced adverse TIAEs were at higher risk of extubation failure and NICU mortality. We have identified key factors strongly associated with adverse TIAEs: 1) patient risk, 2) provider skill, 3) premedication with paralysis, and 4) video laryngoscopy. We have developed, refined, and tested a Personalized Intubation Safety (PINS) Bundle aimed at addressing these factors and prompting a prospective plan for TI management. The prototype Safety Bundle resulted in a sustained 66% reduction in severe TI adverse events in our pilot single center study. In this proposal, we will perform a pragmatic stepped wedge cluster randomized trial across 8 NEAR4NEOS NICUs to assess the impact of the Personalized Intubation Bundle on TI safety events. The timing of introducing the Bundle intervention will be randomized at the NICU site level. Our primary outcome is adverse TIAEs; secondary outcomes are severe TIAEs, multiple (>2) attempts, and magnitude of oxygen desaturation. We will test whether there is a significant variability in the treatment effect of the PINS Bundle based on the airway provider skill. This will provide important information about the impact of the Bundle intervention and its components for novice vs. experienced providers, which will help NICUs to contextualize study findings. Finally, we will explore the impact of the PINS Bundle intervention on relevant NICU patient outcomes, including extubation failure, duration of mechanical ventilation, intraventricular hemorrhage, and NICU mortality. Upon successful completion of this project, we will establish the effectiveness of a prospective Personalized Intubation Safety Bundle to reduce adverse events, multiple attempts and oxygen desaturation during neonatal TI. These results will generate a paradigm shift to improve neonatal intubation procedural safety.

项目摘要 气管插管（TI）是一种常见的挽救生命的干预措施，用于复苏新生儿的重症婴儿 重症监护病房（NICUS）。通过我们的NICHD资助的NICU多中心注册表（国家紧急情况 Airway Neonates：近4NEO），我们已经确定了不良Ti相关的事件（TIAES） 发生在22％的TI中，在4％TI中发生严重的TIAE，并且在23％的TI中发生多次尝试。氧 去饱和（与TIAE分开捕获）是频繁且明显的，平均下降了28％ 新生儿Ti期间的spo2。此外，经历不良发病的新生儿的风险更高 拔管失败和NICU死亡率。 我们已经确定了与不良反应密切相关的关键因素：1）患者风险，2）提供商技能，3） 瘫痪和4）视频喉镜检查。我们已经开发，完善和测试了 个性化的插管安全（PIN）捆绑包，旨在解决这些因素并促使潜在的 计划管理计划。原型安全捆绑包导致严重Ti的持续减少66％ 我们的单一中心研究中的不良事件。 在此提案中，我们将在8个附近的8个NEOS上执行务实的梯级楔形群集随机试验 NICUS评估个性化插管捆绑包对TI安全事件的影响。时机 引入捆绑干预措施将在NICU站点级别随机分组。我们的主要结果是不利的 提示；次要结局是严重的TIAE，多个（> 2）尝试和氧气去饱和度的大小。 我们将根据基于PIN束的治疗效应有显着差异 气道提供商技能。这将提供有关捆绑干预及其影响的重要信息 新手与经验丰富的提供商的组件，这将有助于NICUS将研究结果与之相关。 最后，我们将探讨针束干预对相关NICU患者结果的影响， 包括拔管故障，机械通气的持续时间，脑室内出血和NICU 死亡。 成功完成该项目后，我们将建立潜在个性化的有效性 插管安全束以减少新生儿期间的不良事件，多次尝试和氧气去饱和 ti。这些结果将产生范式转变，以提高新生儿插管程序安全性。