Treating Respiratory Emergencies in Children Study (T-RECS)

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma in Children
• Intervention / Treatment: Drug: Ipratropium Bromide

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Matthew L Hansen, MD, MCR; Phone Number: 503494-7500; Email: hansemat@ohsu.edu
• Study Contact Backup: Name: Denise Griffiths; Phone Number: 503-494-7015; Email: griffitd@ohsu.edu

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14261
      • Recruiting
      • University at Buffalo
      • Contact: Brooke Lerner, PhD; Phone Number: 716-645-9726; Email: lerner@buffalo.edu
  • North Carolina
    • Charlotte, North Carolina, United States, 28208
      • Not yet recruiting
      • Mecklenburg County EMS
      • Contact: Jon Studnek; Phone Number: 704-943-6000; Email: jonst@medic911.com
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • University of Utah
      • Contact: Sarah Becker, DO; Phone Number: 801-587-7450; Email: sarah.becker@hsc.utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful primary and secondary outcome measurement among participants	We will evaluate the feasibility of collecting the main study outcomes among study participants	Through 8 days after enrollment
Proportion of patients who require a critical care intervention	Use of bag mask ventilation, non-invasive positive pressure ventilation, endotracheal intubation, high-flow nasal cannula, Extra Corporeal Membrane Oxygenation (ECMO), and Cardio Pulmonary Resuscitation (CPR)	Within one week of the index EMS encounter

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: Wake Forest University Health Sciences; University at Buffalo; University of Utah
• Investigators: Principal Investigator: Matthew L Hansen, MD, MCR, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): September 7, 2025

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anticonvulsants; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Dexamethasone; Bromides; Ipratropium
• Other Study ID Numbers: 00138724

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No