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1/2 – Pediatric Prehospital Airway Resuscitation Trial

1/2 — 儿科院前气道复苏试验

基本信息

批准号：
10738581
负责人：
Henry E. Wang
金额：
$ 190.27万
依托单位：
OHIO STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-01 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10738581
关键词：
Accounting Address Adverse event Age Agreement Applied Research Bayesian Analysis Benefits and Risks Brain Caring Categories Child Child Care Child Health Childhood Clinical Clinical Trials Network Communities Complement Complex Consensus Critical Care Critical Illness Critically ill children Databases Dedications Devices Disease Dose Emergency Care Emergency research Ensure Event Gel Guidelines Heart Heart Arrest Hospitals Informed Consent Institutional Review Boards International Interview Intratracheal Intubation Knowledge Laryngeal Masks Larynx Life Lung Manuals Masks Outcome Oxygen Paramedical Personnel Patients Pediatric Hospitals Phase Physician Executives Pre-hospitalization care Protocols documentation Public Health Recommendation Resources Respiratory Failure Resuscitation Safety Secure Seizures Survival Rate Techniques Testing Training Trauma Traumatic injury Tube United States Agency for Healthcare Research and Quality United States Health Resources and Services Administration Variant clinical care community consultation compare effectiveness design evidence base experience improved innovation multidisciplinary novel operation out-of-hospital cardiac arrest pediatric emergency prevent relative effectiveness skills synergism trial design trial enrollment ventilation

项目摘要

PROJECT SUMMARY We aim to answer the signature question of paramedic care; “What is the best way to manage the prehospital airway in critically ill children?” Cardiac arrest, respiratory failure, and major trauma are devastating critical conditions in children. Resuscitation from critical illness requires skillful airway management to optimize delivery of oxygen to the lungs, preventing irreparable damage to the brain and heart. As the first to provide critical care, prehospital paramedics often perform life-saving airway management on critically ill children. The most common prehospital airway management techniques (bag-valve-mask ventilation (BVM), endotracheal intubation (ETI), and supraglottic airway insertion (SGA) have important trade- offs between risks and benefits; the best approach is unknown. We propose the novel Pediatric Prehospital Airway Resuscitation Trial (Pedi-PART) to determine the best strategies for prehospital airway management in critically ill children. Pedi-PART will immediately influence paramedic practices and have a lasting impact upon the health of children internationally. We will determine the relative effectiveness of three airway strategies ([BVM-only], [BVM+ETI], [BVM+SGA]), accounting for variations across disease (cardiac arrest, trauma, respiratory failure) and age categories, and we will apply adaptive techniques to minimize the required number of patients. Our aims are: AIM I: Prepare the Pediatric Emergency Care Applied Research Network (PECARN) to execute the innovative Pedi-PART trial. PECARN is the nation’s premier pediatric emergencies research network. We have assembled an alliance of over 60 EMS agencies from 10 communities associated with PECARN and their ongoing Pediatric Dose Optimization for Seizures in EMS trial (PediDOSE - U01-NS114042). AIM II: Compare the effectiveness of prehospital BVM, SGA, and ETI airway management strategies upon pediatric cardiac arrest, major trauma, and respiratory failure outcomes. We will execute the trial in two sequential stages. Stage I: Determine if [BVM-only] or [BVM followed by SGA] results in better ICU-free survival in critically ill children with cardiac arrest, major trauma, or respiratory failure. Stage II: Determine if [winner of Stage I] or [BVM followed by ETI] results in better ICU-free survival. AIM III: Compare the safety of prehospital BVM, SGA, and ETI airway management strategies in pediatric cardiac arrest, major trauma, and respiratory failure. In Stage I, we will determine if [BVM+SGA] results in fewer prehospital and hospital adverse events compared with [BVM-only] in critically ill children with cardiac arrest, major trauma, or respiratory failure. In Stage II, we will determine if the winner of Stage I results in fewer adverse events compared with [BVM+ETI].

项目概要我们的目标是回答护理人员护理的标志性问题； “最好的管理方式是什么？危重儿童院前气道？心脏骤停、呼吸衰竭和严重外伤儿童的毁灭性危急状况。危重病复苏需要熟练的气道优化向肺部输送氧气的管理，防止对大脑造成不可挽回的损害心。作为第一个提供重症监护的人员，院前护理人员经常进行挽救生命的气道管理对危重儿童。最常见的院前气道管理技术（球袋-阀门-面罩）通气 (BVM)、气管插管 (ETI) 和声门上气道插入 (SGA) 具有重要的权衡风险与收益之间的偏差；最好的方法尚不清楚。我们提出新颖的儿科院前气道复苏试验 (Pedi-PART) 来确定危重儿童院前气道管理的最佳策略。 Pedi-PART 将立即影响护理人员的做法并对儿童的健康产生持久的影响国际上。我们将确定三种气道策略的相对有效性（[仅 BVM]、[BVM+ETI]、 [BVM+SGA]），考虑了疾病（心脏骤停、创伤、呼吸衰竭）和年龄的变化类别，我们将应用适应性技术来尽量减少所需的患者数量。我们的目标是：目标 I：准备儿科紧急护理应用研究网络 (PECARN) 以执行创新的 Pedi-PART 试验。 PECARN 是美国首屈一指的儿科紧急情况研究网络。我们组建了一个由来自 10 个与 PECARN 相关社区的 60 多个 EMS 机构组成的联盟及其正在进行的 EMS 试验中针对癫痫发作的儿科剂量优化 (PediDOSE - U01-NS114042)。 AIM II：比较院前 BVM、SGA 和 ETI 气道管理策略的有效性儿童心脏骤停、重大创伤和呼吸衰竭结果。我们将在两个连续的阶段。第一阶段：确定[仅使用 BVM] 或 [BVM 后加 SGA] 是否会带来更好的免 ICU 效果心脏骤停、严重创伤或呼吸衰竭的危重儿童的生存率。第二阶段：确定是否 [第一阶段的获胜者]或[BVM，随后是ETI]可带来更好的无ICU生存率。目标 III：比较院前 BVM、SGA 和 ETI 气道管理策略的安全性小儿心脏骤停、重大创伤和呼吸衰竭。在第一阶段，我们将确定是否[BVM+SGA] 与[仅 BVM] 相比，对于患有以下疾病的危重儿童，院前和院内不良事件较少心脏骤停、重大创伤或呼吸衰竭。在第二阶段，我们将决定第一阶段的获胜者是否取得成绩与 [BVM+ETI] 相比，不良事件更少。