Treating Respiratory Emergencies in Children Study

Asthma in Children Clinical Trial

— T-RECS  

Official title:

Treating Respiratory Emergencies in Children Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06074185
• Other study ID #: 00138724
• Status: Recruiting
• Phase: Phase 2
• Start date: January 19, 2024
• Est. completion date: September 7, 2025

Study information

• Verified date: February 2024
• Source: Oregon Health and Science University
• Contact: Matthew L Hansen, MD, MCR
• Phone: 503494-7500
• Email: hansemat[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 7, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma in Children
• Emergencies

Intervention

Drug:
• Ipratropium Bromide
The study intervention involves implementing a treatment bundle that includes inhaled ipratropium bromide and dexamethasone.

Locations

Country	Name	City	State
United States	University at Buffalo	Buffalo	New York
United States	Mecklenburg County EMS	Charlotte	North Carolina
United States	University of Utah	Salt Lake City	Utah

Sponsors (4)

Lead Sponsor	Collaborator
Oregon Health and Science University	University at Buffalo, University of Utah, Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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