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）是新生儿重症复苏的常见救生干预措施， 重症监护室（NICU）。通过我们的NICHD资助的NICU多中心登记（国家紧急 新生儿气道登记研究：NEAR 4 NEOS），我们已经确定不良TI相关事件（TIAE） 22%的TI发生严重TIAES，4%的TI发生严重TIAES，23%的TI发生多次尝试。氧 去饱和（与TIAE分开捕获）频繁且明显，平均下降28%， 新生儿TI期间的SpO 2。此外，发生不良TIAE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TIAE密切相关的关键因素：1）患者风险，2）提供者技能，3） 麻痹前用药，和4）视频喉镜检查。我们已经开发、完善和测试了一种 个性化插管安全（PINS）套件旨在解决这些因素并促进前瞻性 TI管理计划。原型安全捆绑包导致严重TI持续减少66% 在我们的试点单中心研究中的不良事件。 在本提案中，我们将在8个NEAR 4 NEOS中进行一项实用的阶梯楔形群随机试验。 NICU评估个性化插管套件对TI安全性事件的影响。的时机 将在NICU研究中心水平随机分配引入集束干预的患者。我们的主要结果是 TIAE;次要结局为重度TIAE、多次（>2次）尝试和氧饱和度下降幅度。 我们将根据以下因素测试PINS束的治疗效果是否存在显著变异性： 气道提供者技能。这将提供有关捆绑干预的影响及其 这将有助于NICU将研究结果置于情境中。 最后，我们将探讨PINS束干预对相关NICU患者结局的影响， 包括拔管失败、机械通气持续时间、脑室内出血和NICU mortality. 在这个项目的成功完成后，我们将建立一个前瞻性的个性化的有效性， 插管安全捆绑包可减少新生儿插管期间的不良事件、多次尝试和氧饱和度下降 TI.这些结果将产生一个范式转变，以提高新生儿插管程序的安全性。