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| Name | Class |
|---|---|
| University of Utah | OTHER |
| University at Buffalo | OTHER |
| Wake Forest University Health Sciences | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continue current care | No Intervention | In this arm, participants will be treated using the existing EMS protocol, and evaluate patient outcomes. | |
| Treatment bundle and checklist | Experimental | In this arm, we will implement a new treatment protocol with the study bundle, and evaluate patient outcomes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipratropium Bromide | Drug | The study intervention involves implementing a treatment bundle that includes inhaled ipratropium bromide and dexamethasone. |
|
| 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 |
| 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 |
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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
Agitation, drowsiness, or confusion
Oxygen saturation < 93% on room air
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew L Hansen, MD, MCR | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo | Buffalo | New York | 14261 | United States | ||
| Mecklenburg County EMS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41943480 | Derived | Hansen M, Jacobsen K, Freeman S, Studnek J, Swanson D, Ranjit C, Crady R, Burnett SJ, Clemency B, Becker S, Brant-Zawadzki G, Jung J, Barney BJ. Treating Respiratory Emergencies in Children Study (T-RECS): a pilot trial of prehospital treatment for life-threatening pediatric asthma. J Asthma. 2026 Apr 22:1-9. doi: 10.1080/02770903.2026.2654585. Online ahead of print. |
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The study screened 302 patients and enrolled 44, with one participant later found ineligible for having respiratory distress not caused by bronchospasm/wheeze, leading to 43 eligible patients with data available for analysis. The post-intervention phase accounted for 155 (51.3%) screened patients and 32 (72.7%) enrolled patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Enrollment under usual care |
| FG001 | Intervention Treatment Bundle | Enrollment with the intervention treatment bundle |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-intervention (6 months) |
|
| ||||||||||||||||||
| Post-intervention (7 months) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-intervention | Enrolled under usual care before the intervention was introduced. |
| BG001 | Post-intervention | Enrolled after the study intervention and checklist were introduced. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | Within 24 hours of the index EMS encounter |
|
|
From enrollment until 24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Continue Current Care | In this arm, participants will be treated using the existing EMS protocol, and evaluate patient outcomes. |
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The study was not originally powered or designed to evaluate these outcomes. Further, the study spanned approximately one year, so seasonal variation in the causes of wheezing could have differed between the phases and impacted the results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matt Hansen, Professor of Emergency Medicine | Oregon Health & Science University | 503-418-2291 | hansemat@ohsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2024 | Sep 11, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009241 | Ipratropium |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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This is a before-and-after study
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|
| Charlotte |
| North Carolina |
| 28208 |
| United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Counts |
|---|
| Participants |
|
|
| 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. | Posted | Mean | Full Range | Score | 6-8 days after the index EMS encounter |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Treatment Bundle and Checklist | In this arm, we will implement a new treatment protocol with the study bundle, and evaluate patient outcomes. | 0 | 32 | 0 | 32 | 0 | 32 |
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| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |