Asthma in Children
Conditions
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.
Interventions
DRUGIpratropium Bromide
The study intervention involves implementing a treatment bundle that includes inhaled ipratropium bromide and dexamethasone.
Sponsors
Oregon Health and Science University
University of Utah
University at Buffalo
Wake Forest University Health Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a before-and-after study
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Admitted to the Hospital in Each Group | Within 24 hours of the index EMS encounter | Whether or not the patient was admitted to the hospital after the index EMS encounter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NIH Patient-Reported Outcomes Measurement Information Systems (PROMIS) Asthma Impact Scale | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMatthew L Hansen, MD, MCR
Oregon Health and Science University
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 5 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 32 |
| other Total, other adverse events | 0 / 11 | 0 / 32 |
| serious Total, serious adverse events | 0 / 11 | 0 / 32 |
Outcome results
None listed