Treating Respiratory Emergencies in Children Study
Status:
Recruiting
Trial end date:
2025-09-07
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Oregon Health and Science University
Collaborators:
University at Buffalo University of Utah Wake Forest University Health Sciences