Asthma
Conditions
Brief summary
The purpose of this study is to compare clinical outcomes related to the current practice of using a jet nebulizer (JN) with aerosol mask (AM) or mouthpiece (MP) versus a vibrating mesh nebulizer (VMN) with a valved-mask (VM) or MP in the treatment of acute moderate to severe asthma in Children's Medical Center Dallas Emergency Department (CMCED).
Detailed description
The purpose of this study is to compare clinical outcomes related to the current practice of using a jet nebulizer (JN) with aerosol mask (AM) or mouthpiece (MP) versus a vibrating mesh nebulizer (VMN) with a valved-mask (VM) or MP in the treatment of acute moderate to severe asthma in Children's Medical Center Dallas Emergency Department (CMCED). The investigators hypothesize that using the combination of a VMN and VM or MP will result in fewer hospital admissions and decrease length of stay in CMCED when compared to the current practice of using a JN and AM or MP.
Interventions
DEVICEJet Nebulizer
Standard single patient-use small volume JN (AirLife™ Sidestream® High-Efficiency Nebulizer, CareFusion, Yorba Linda, CA)
DEVICEVibrating Mesh Nebulizer
Vibrating Mesh Nebulizer (Aerogen® Solo with Ultra adapter, Aerogen Ltd, Galway, Ireland)
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
2 to 18 year old (up to 19th birthday) otherwise healthy children with primary diagnosis of acute moderate to severe exacerbation of asthma presenting to Children's Medical Center Emergency Department, Dallas \-
Exclusion criteria
* Children \< 2 years old * Children with comorbid/complex medical conditions such as: congenital or acquired cardiovascular disease, cystic fibrosis, chronic lung disease (other than asthma), bronchopulmonary dysplasia, airway anomalies (e.g., tracheomalacia) or immunodeficiency syndromes. * Patients with coexisting medical condition such as pneumonia * Patients in impending respiratory failure as determined by treating physician * Patients that have had oral corticosteroids within 24hrs of CMCED admission * Patients that have had bronchodilator treatment within one hour of CMCED admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Hospitalized | Within emergency department visit time frame (no more than 12 hours) | The primary outcome measure is rate of hospitalization between the two treatment groups overall |
Secondary
| Measure | Time frame |
|---|---|
| Number of Treatments Required to Achieve Mild Asthma Score - Discharge Criteria | Within emergency department visit time frame (no more than 12 hours) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control - Jet Nebulizer The control group used our standard single patient-use small volume JN (AirLife™ Sidestream® High-Efficiency Nebulizer, CareFusion, Yorba Linda, CA) operated at 7 L/min per manufacture's guidelines. | 109 |
| Study - Vibrating Mesh Nebulizer The study group used a VMN (Aerogen® Solo with Ultra adapter, Aerogen Ltd, Galway, Ireland) that is an electronically powered nebulizer. | 108 |
| Total | 217 |
Baseline characteristics
| Characteristic | Control - Jet Nebulizer | Total | Study - Vibrating Mesh Nebulizer |
|---|---|---|---|
| Age, Categorical <=18 years | 109 Participants | 217 Participants | 108 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 6.0 years | 7.0 years | 7.0 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 46 Participants | 88 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 63 Participants | 129 Participants | 66 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Moderate Asthma | 63 Participants | 109 Participants | 46 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 59 Participants | 121 Participants | 62 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 48 Participants | 93 Participants | 45 Participants |
| Region of Enrollment United States | 109 Participants | 217 Participants | 108 Participants |
| Severe Asthma | 46 Participants | 108 Participants | 62 Participants |
| Sex: Female, Male Female | 73 Participants | 146 Participants | 73 Participants |
| Sex: Female, Male Male | 36 Participants | 71 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 109 | 0 / 108 |
| other Total, other adverse events | 0 / 109 | 0 / 108 |
| serious Total, serious adverse events | 0 / 109 | 0 / 108 |
Outcome results
Primary
Number of Subjects Hospitalized
The primary outcome measure is rate of hospitalization between the two treatment groups overall
Time frame: Within emergency department visit time frame (no more than 12 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control - Jet Nebulizer | Number of Subjects Hospitalized | 22 Participants |
| Study - Vibrating Mesh Nebulizer | Number of Subjects Hospitalized | 15 Participants |
Secondary
Number of Treatments Required to Achieve Mild Asthma Score - Discharge Criteria
Time frame: Within emergency department visit time frame (no more than 12 hours)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control - Jet Nebulizer | Number of Treatments Required to Achieve Mild Asthma Score - Discharge Criteria | 3.0 number of treatments |
| Study - Vibrating Mesh Nebulizer | Number of Treatments Required to Achieve Mild Asthma Score - Discharge Criteria | 2 number of treatments |