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临床试验/NCT06074185
NCT06074185已完成2 期

Treating Respiratory Emergencies in Children Study

Oregon Health and Science University6 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年1月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
44
试验地点
6
主要终点
Proportion of patients admitted to the hospital in each group

研究概览

简要总结

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 children with life-threatening wheezing 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). The investigators will include patients aged 2-17 who have a 911 call for acute life-threatening 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 the implementation of the EMS treatment bundle and checklist using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Our overall hypothesis is that the study will be feasible to implement. 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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
2 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Ages 2-17 years; AND
  • Transported by EMS through 911 activation; AND
  • Prior history of wheeze/asthma, current asthma symptoms (dyspnea or wheeze); AND
  • At least 4 of the following:
  • Visible use of accessory muscles/retractions
  • Inspiratory and expiratory wheezing or silent chest
  • Abnormal respiratory rate for age
  • For < 6 years ≥ 46 breaths/min
  • For ≥ 6 years ≥ 36 breaths/min
  • Agitation, drowsiness, or confusion
  • Oxygen saturation < 93% on room air

排除标准

  • History of albuterol, ipratropium, or dexamethasone allergy
  • Known or suspected pregnancy
  • Suspected airway foreign body
  • Respiratory distress not due to bronchospasm/wheeze
  • Parent, legally authorized representative (LAR), subject, and/or family member objects to participation prior to treatment

研究组 & 干预措施

Continue current care

No Intervention

In this arm, participants will be treated using the existing EMS protocol, and evaluate patient outcomes.

Treatment bundle and checklist

Experimental

In this arm, we will implement a new treatment protocol with the study bundle, and evaluate patient outcomes.

干预措施: Ipratropium Bromide (Drug)

结局指标

主要结局

Proportion of patients admitted to the hospital in each group

时间窗: Within 24 hours of the index EMS encounter

Whether or not the patient was admitted to the hospital after the index EMS encounter

Proportion of Patients Admitted to the Hospital in Each Group

时间窗: Within 24 hours of the index EMS encounter

Whether or not the patient was admitted to the hospital after the index EMS encounter

次要结局

  • NIH Patient-Reported Outcomes Measurement Information Systems (PROMIS) asthma impact scale(6-8 days after the index EMS encounter)
  • NIH Patient-Reported Outcomes Measurement Information Systems (PROMIS) Asthma Impact Scale(6-8 days after the index EMS encounter)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matt Hansen

Professor

Oregon Health and Science University

研究点 (6)

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