Treating Respiratory Emergencies in Children Study

Study Overview
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Brief Summary
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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.

Official Title
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Treating Respiratory Emergencies in Children Study

Conditions
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Asthma in Children

Intervention / Treatment
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* Drug: Ipratropium Bromide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: History of albuterol, ipratropium, or dexamethasone allergy Known or suspected pregnancy Prisoner Croup 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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a before-and-after study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Continue current care<br>In this arm, participants will be treated using the existing EMS protocol, and evaluate patient outcomes. | |
| Experimental: Treatment bundle and checklist<br>In this arm, we will implement a new treatment protocol with the study bundle, and evaluate patient outcomes. | Drug: Ipratropium Bromide<br>* The study intervention involves implementing a treatment bundle that includes inhaled ipratropium bromide and dexamethasone.<br>* Other names: dexamethasone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients admitted to the hospital in each group | Whether or not the patient was admitted to the hospital after the index EMS encounter | Within 24 hours of the index EMS encounter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIH Patient-Reported Outcomes Measurement Information Systems (PROMIS) asthma impact scale | Quality of life score for asthma. Range 0-100. A higher score equates to poorer quality of life. | 6-8 days after the index EMS encounter |