Treating Respiratory Emergencies in Children Study (T-RECS)

Oregon Health & Science University (OHSU)

Status and phase: Enrolling; Phase 2

Conditions: Asthma in Children

Treatments: Drug: Ipratropium Bromide

Study type: Interventional

Funder types: Other

Identifiers

NCT06074185

00138724

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Continue current care

No Intervention group

Description:

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

Treatment bundle and checklist

Experimental group

Description:

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

Treatment:

Drug: Ipratropium Bromide