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OpenTrials
Completed

NCT Number: NCT06074185

Treating Respiratory Emergencies in Children Study

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.

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Key information

Conditions

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University at Buffalo, Buffalo, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ipratropium bromide

Drug

The study intervention involves implementing a treatment bundle that includes inhaled ipratropium bromide and dexamethasone.

Other names: dexamethasone

Primary outcomes

  1. Proportion of Patients Admitted to the Hospital in Each Group

    Time frame: Within 24 hours of the index EMS encounter

    Whether or not the patient was admitted to the hospital after the index EMS encounter

Secondary outcomes

  1. NIH Patient-Reported Outcomes Measurement Information Systems (PROMIS) Asthma Impact Scale

    Time frame: 6-8 days after the index EMS encounter

    Quality of life score for asthma. Range 0-100. A higher score equates to poorer quality of life.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • University at Buffalo
  • University of Utah
  • Wake Forest University Health Sciences

Registry information

Acronym: T-RECS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2023
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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