Treating Respiratory Emergencies in Children (T-RECS) Feasibility Study

治疗儿童呼吸急症 (T-RECS) 可行性研究

• 批准号: 10370791
• 负责人: Matthew Lee Hansen
• 金额: $ 37.37万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10370791
• 关键词: 2 year old; 911 call; Accident and Emergency department; Acute; Address; Admission activity; Adrenal Cortex Hormones; Advisory Committees; Albuterol; Applied Research; Area; Asthma; Caring; Child; Childhood; Childhood Asthma; Clinical; Clinical Trials; Community Hospitals; Data; Dexamethasone; Diagnosis; Early treatment; Effectiveness; Emergency Care; Emergency Situation; Emergency medical service; Ensure; Environment; Feasibility Studies; Feedback; Goals; Health; Hospitalization; Hospitals; Hybrids; Hypoxia; Inhalation; Intervention; Intravenous; Ipratropium; Methods; Methylprednisolone; Modeling; Needles; Oral; Oral Administration; Outcome; Outcome Measure; Paramedical Personnel; Patient-Focused Outcomes; Patients; Pediatric Research; Pharmaceutical Preparations; Phenotype; Pilot Projects; Pre-hospital setting; Pre-hospitalization care; Protocols documentation; Provider; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recommendation; Recording of previous events; Research; Research Infrastructure; Resources; Respiratory Signs and Symptoms; Respiratory distress; Safety; Signs and Symptoms; Site; Structure; Surveys; Symptoms; System; Time; Training; Treatment Protocols; United States National Institutes of Health; Wheezing; acceptability and feasibility; aged; care systems; design; evidence base; hospital admission rate; implementation evaluation; implementation intervention; improved; innovation; interest; metropolitan; neglect; participant enrollment; pediatric emergency; pilot trial; prevent; randomized trial; respiratory; service organization; service providers; standard of care; study population; treatment risk; treatment services

Over 200,000 children have a 911 Emergency Medical Services (EMS) activation for respiratory distress each year, most of whom have acute wheezing. Early treatment in the prehospital setting could more rapidly relieve respiratory distress symptoms, prevent hypoxia, reduce invasive interventions, and reduce the need to be hospitalized, thereby facilitating earlier return to normal daily activities. Preliminary data from one site found hospital admission was reduced from 30% to 21% among children when an EMS system introduced a pediatric asthma protocol with oral dexamethasone. The current standard for Emergency Department (ED) treatment for acute wheezing for children two and older includes inhaled ipratropium and dexamethasone. These treatments have a longstanding history of safety and are effective in preventing hospitalization when used early in the ED. Specific treatment protocols generally direct prehospital care. Ipratropium and dexamethasone are recommended by national EMS organizations that develop model protocols for prehospital care. However, only 25% of EMS agencies from large US metropolitan areas allow ipratropium, and only 10% include dexamethasone in their treatment protocols. A clinical trial is critically needed to evaluate whether the significant EMS resources required to implement interventions for wheezing children that have proven benefit in the ED result in improved patient outcomes. The overall objective of this three-site pilot trial is to address specific questions related to the implementation of the study and ensure its feasibility. The study will be conducted in the Pediatric Emergency Care Applied Research Network (PECARN) EMS Affiliates (EMSAs). We will include patients aged 2-18 who have a 911 call for acute wheezing. The specific aims are 1) to develop and produce a prehospital checklist for the treatment bundle including ipratropium and dexamethasone, 2) to determine the feasibility of collecting patient outcomes for wheezing children treated in the EMS system, and 3) to evaluate implementation of the EMS treatment bundle and checklist using the RE-AIM framework. This study will provide the necessary data to ensure the eventual trial is feasible, primarily by establishing the ability to measure the outcomes of interest as well as evaluating implementation. This study is innovative by focusing on pediatric care in the prehospital environment, a critical component of our emergency care system that is often neglected in research.

超过20万名儿童因呼吸窘迫而启动911紧急医疗服务（EMS）， 年，其中大多数人有急性喘息。院前早期治疗可以更快地缓解 呼吸窘迫症状，防止缺氧，减少侵入性干预，并减少需要 住院，从而促进早日恢复正常的日常活动。一个网站的初步数据发现， 当EMS系统引入儿科时，儿童的住院率从30%降低到21%。 哮喘方案与口服地塞米松。急诊科（艾德）治疗的现行标准是 两岁及以上儿童的急性喘息包括吸入异丙托溴铵和地塞米松。这些治疗 具有长期的安全性历史，并且在ED早期使用时可有效防止住院。 具体的治疗方案通常指导院前护理。异丙托溴铵和地塞米松是 由国家EMS组织推荐，该组织为院前护理开发了模型协议。但只有 25%的美国大城市EMS机构允许使用异丙托铵，只有10%的机构包括 地塞米松在他们的治疗方案。迫切需要进行临床试验，以评估 需要大量EMS资源来实施已证明有益的喘息儿童干预措施 在艾德中的应用改善了患者的预后。这三个中心的试点试验的总体目标是解决 与研究实施有关的具体问题，并确保其可行性。本研究将 在儿科急救护理应用研究网络（PECARN）EMS附属机构（EMSA）中进行。 我们将纳入2-18岁因急性喘息而拨打911的患者。具体目标是：（1）发展 并为包括异丙托溴铵和地塞米松在内的治疗组合制定院前检查清单，2） 确定收集EMS系统中治疗的喘息儿童的患者结局的可行性，以及3） 使用RE-AIM框架评价EMS治疗包和检查表的实施。这 研究将提供必要的数据，以确保最终试验是可行的，主要是通过建立能力 以衡量感兴趣的成果以及评估实施情况。本研究的创新之处在于， 关于院前环境中的儿科护理，这是我们急诊护理系统的关键组成部分， 在研究中经常被忽视。