Treating Respiratory Emergencies in Children Study

NCT ID: NCT06074185

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-19
• Study Completion Date: 2025-03-11

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.

Conditions

Asthma in Children

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Continue current care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment bundle and checklist

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

Group Type: EXPERIMENTAL

Ipratropium Bromide

Intervention Type: DRUG

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

Interventions

Ipratropium Bromide

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

Intervention Type: DRUG

Other Intervention Names

dexamethasone

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: collaborator

University at Buffalo

OTHER

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Matt Hansen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew L Hansen, MD, MCR

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

University at Buffalo

Buffalo, New York, United States

Mecklenburg County EMS

Charlotte, North Carolina, United States

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

00138724

Identifier Type: -

Identifier Source: org_study_id