Bosson Nichole, Hansen Matthew, Gausche-Hill Marianne, Lewis Roger J, Wendelberger Barbara, Shah Manish I, VanBuren John M, Wang Henry E
Los Angeles County Emergency Medical Services Agency, Santa Fe Springs, CA, USA.
David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
Clin Trials. 2022 Feb;19(1):62-70. doi: 10.1177/17407745211059855. Epub 2021 Dec 7.
Emergency Medical Services personnel are often the first to intervene in the care of critically ill children. Airway management is a fundamental step in prehospital resuscitation, yet there is significant variation in current prehospital airway management practices. Our objective is to present a methodologic approach to determine the optimal strategy for prehospital pediatric airway management. We describe the conceptual premise for the Pediatric Prehospital Airway Resuscitation Trial, a novel Bayesian adaptive sequential platform trial. We developed an innovative design to enable comparison of the three predominant prehospital pediatric airway techniques (bag-mask-ventilation, supraglottic airway insertion, and endotracheal intubation) in three distinct disease groups (cardiac arrest, major trauma, and other respiratory failure). We used a Bayesian statistical approach to provide flexible modeling that can adapt based on prespecified rules according to accumulating trial data with patient enrollment continuing until stopping rules are met. The approach also allows the comparison of multiple interventions in sequence across the different disease states. This Bayesian hierarchical model will be the primary analysis method for the Pediatric Prehospital Airway Resuscitation Trial. The model integrates information across subgroups, a technique known as "borrowing" to generate accurate global and subgroup-specific estimates of treatment effects and enables comparisons of airway intervention arms within the overarching trial. We will use this Bayesian hierarchical linear model that adjusts for subgroup to estimate treatment effects within each subgroup. The model will predict a patient-centered score of 30-day intensive care unit-free survival using arm, subgroup, and emergency medical services agency as predictors. The novel approach of Pediatric Prehospital Airway Resuscitation Trial will provide a feasible method to determine the optimal strategy for prehospital pediatric airway management and may transform the design of future prehospital resuscitation trials.
紧急医疗服务人员通常是首批参与危重症儿童护理的人员。气道管理是院前复苏的基本步骤，但目前院前气道管理实践存在显著差异。我们的目标是提出一种方法，以确定院前儿科气道管理的最佳策略。我们描述了儿科院前气道复苏试验的概念前提，这是一项新型的贝叶斯适应性序贯平台试验。我们开发了一种创新设计，以便在三个不同疾病组（心脏骤停、重大创伤和其他呼吸衰竭）中比较三种主要的院前儿科气道技术（袋面罩通气、声门上气道插入和气管插管）。我们采用贝叶斯统计方法提供灵活的模型，该模型可根据预先设定的规则，根据累积的试验数据进行调整，同时患者入组持续进行，直至满足停止规则。该方法还允许在不同疾病状态下依次比较多种干预措施。这种贝叶斯分层模型将是儿科院前气道复苏试验的主要分析方法。该模型整合了亚组间的信息，这是一种称为“借用”的技术，用于生成准确的总体和亚组特异性治疗效果估计值，并能够在总体试验中比较气道干预组。我们将使用这种针对亚组进行调整的贝叶斯分层线性模型来估计每个亚组内的治疗效果。该模型将以手臂、亚组和紧急医疗服务机构作为预测因子，预测以患者为中心的30天无重症监护病房生存率得分。儿科院前气道复苏试验的新方法将提供一种可行的方法来确定院前儿科气道管理的最佳策略，并可能改变未来院前复苏试验的设计。
