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）

基本信息

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
项目类别：
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

项目摘要

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.

项目概要气管插管（TI）是新生儿危重婴儿复苏的常见救生干预措施重症监护病房 (NICU)。通过我们的 NICHD 资助的 NICU 多中心登记处（国家紧急情况新生儿气道登记：NEAR4NEOS），我们已确定不良 TI 相关事件 (TIAE) 22% 的 TI 中发生了严重的 TIAES，4% 的 TI 中发生了严重的 TIAES，23% 的 TI 中发生了多次尝试。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 SpO2。此外，经历过不良 TIAE 的新生儿发生以下疾病的风险更高：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，4) 视频喉镜检查。我们开发、完善并测试了个性化插管安全 (PINS) 捆绑包旨在解决这些因素并促进前瞻性 TI 管理计划。原型安全包使严重 TI 持续减少 66% 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 NEAR4NEOS 上进行实用的阶梯式楔形聚类随机试验 NICU 评估个性化插管套件对 TI 安全事件的影响。的时间安排引入捆绑干预措施将在新生儿重症监护病房 (NICU) 站点级别进行随机分配。我们的主要结果是不良的 TIAE；次要结局是严重的 TIAE、多次 (>2) 尝试以及氧饱和度下降的程度。我们将根据以下情况测试 PINS 捆绑包的治疗效果是否存在显着差异：气道提供者的技能。这将提供有关捆绑干预措施及其影响的重要信息适合新手与经验丰富的提供者的组件，这将有助于新生儿重症监护室将研究结果结合起来。最后，我们将探讨 PINS Bundle 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 死亡。成功完成该项目后，我们将确定未来个性化的有效性插管安全套装可减少新生儿期间的不良事件、多次尝试和氧饱和度下降 TI。这些结果将产生范式转变，以提高新生儿插管程序的安全性。