Clinical trial NCT06074185: Treating Respiratory Emergencies in Children Study
Official title: Treating Respiratory Emergencies in Children Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma in Children
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: University of Utah
name: University at Buffalo
name: Wake Forest University Health Sciences
First posted: 2023-10-10
Enrollment: 44
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a before-and-after study
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Ages 2-17 years; AND
2. Transported by EMS through 911 activation; AND
3. Prior history of wheeze/asthma, current asthma symptoms (dyspnea or wheeze); AND
4. 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:

1. History of albuterol, ipratropium, or dexamethasone allergy
2. Known or suspected pregnancy
3. Prisoner
4. Croup
5. Suspected airway foreign body
6. Respiratory distress not due to bronchospasm/wheeze
7. Parent, legally authorized representative (LAR), subject, and/or family member objects to participation prior to treatment

Primary outcomes:
measure: Proportion of patients admitted to the hospital in each group
timeFrame: Within 24 hours of the index EMS encounter
Secondary outcomes:
measure: NIH Patient-Reported Outcomes Measurement Information Systems (PROMIS) asthma impact scale
timeFrame: 6-8 days after the index EMS encounter
Other outcomes:
measure: Rate of successful primary and secondary outcome measurement among participants
timeFrame: Through 8 days after enrollment
measure: Proportion of patients who require a critical care intervention
timeFrame: Within one week of the index EMS encounter
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: Charlotte
country: United States
facility: Mecklenburg County EMS
state: North Carolina
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Oregon Health and Science University
name: Matthew L Hansen, MD, MCR
role: PRINCIPAL_INVESTIGATOR
References: