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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Standard single patient-use small volume JN (AirLife™ Sidestream® High-Efficiency Nebulizer, CareFusion, Yorba Linda, CA) |
|
| Study | Experimental | Vibrating Mesh Nebulizer (Aerogen® Solo with Ultra adapter, Aerogen Ltd, Galway, Ireland) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jet Nebulizer | Device | Standard single patient-use small volume JN (AirLife™ Sidestream® High-Efficiency Nebulizer, CareFusion, Yorba Linda, CA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Hospitalized | The primary outcome measure is rate of hospitalization between the two treatment groups overall | Within emergency department visit time frame (no more than 12 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatments Required to Achieve Mild Asthma Score - Discharge Criteria | Within emergency department visit time frame (no more than 12 hours) |
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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
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Medical Center | Dallas | Texas | 75235 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32209712 | Derived | Moody GB, Luckett PM, Shockley CM, Huang R, Ari A. Clinical Efficacy of Vibrating Mesh and Jet Nebulizers With Different Interfaces in Pediatric Subjects With Asthma. Respir Care. 2020 Oct;65(10):1451-1463. doi: 10.4187/respcare.07538. Epub 2020 Mar 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Two children were excluded who were discharged after an initial decision to admit was made and treated after study procedure ended, and one child was excluded after the diagnosis of pneumonia was made.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Study - Vibrating Mesh Nebulizer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Subjects Hospitalized | The primary outcome measure is rate of hospitalization between the two treatment groups overall | Posted | Count of Participants | Participants | Within emergency department visit time frame (no more than 12 hours) |
|
Adverse event data were collected over treatment period ranging from 1 to 3 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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator - Respiratory Care Dept | Children's Health - Children's Medical Center, Dallas | 214-456-1367 | gerald.moody@childrens.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 15, 2019 | Jan 21, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Vibrating Mesh Nebulizer | Device | Vibrating Mesh Nebulizer (Aerogen® Solo with Ultra adapter, Aerogen Ltd, Galway, Ireland) |
|
The study group used a VMN (Aerogen® Solo with Ultra adapter, Aerogen Ltd, Galway, Ireland) that is an electronically powered nebulizer. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Moderate Asthma | Count of Participants | Participants |
|
| Severe Asthma | Count of Participants | Participants |
|
|
|
| Secondary | Number of Treatments Required to Achieve Mild Asthma Score - Discharge Criteria | Posted | Median | Inter-Quartile Range | number of treatments | Within emergency department visit time frame (no more than 12 hours) |
|
|
|
| 0 |
| 109 |
| 0 |
| 109 |
| 0 |
| 109 |
| EG001 | 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. | 0 | 108 | 0 | 108 | 0 | 108 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |