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change in availability of study investigators
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A Breath-Actuated Nebulizer is a newer type of nebulizer device that creates aerosol only when a patient is inhaling, rather than creating aerosol continuously. It is thought that breath-actuated nebulizer devices may deliver asthma rescue medications to patients' lungs more effectively and therefore lead them to recover from asthma attacks faster than conventional continuous-output nebulizer devices. This study compares outcomes including hospital admission rates, number of nebulized treatments required, and patient/family satisfaction when a breath-actuated nebulizer device versus a conventional continuous-output nebulizer is used to deliver asthma medications to pediatric asthma patients in the emergency department.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breath-Actuated Nebulizer | Active Comparator | Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. |
|
| Conventional continuous-ouput nebulizer | Active Comparator | Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebulizer (breath-actuated versus conventional continuous-output) | Device | Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol are used in both devices. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Admission to Hospital for Asthma Exacerbation | Number (and percentage) of children in each study group requiring admission to the hospital for asthma exacerbation/status asthmaticus from the Pediatric Emergency Department (as opposed to being discharged to home) | 24 hours (whether patient is admitted after presenting to emergency department for asthma or discharged home) |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay in the Emergency Department After Presenting for Asthma Exacerbation | Length of stay in the emergency department measured in minutes; up to 400 minutes measured | only measures length of stay in emergency department on date of presentation |
| Patient's Satisfaction With Using Assigned Nebulizer (as Assessed by Brief Survey) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerri A Rose, M.D. | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rainbow Babies and Children's Hospital/University Hospitals of Cleveland Pediatric Emergency Department | Cleveland | Ohio | 44106 | United States |
180 participants were enrolled in the study. No enrolled participants were excluded from the study before assignment to groups.
Study participants recruited from eligible children who presented to a pediatric emergency department at the single study site with acute asthma exacerbation/status asthmaticus. Recruitment for this study is now closed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Breath-Actuated Nebulizer | Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Nebulizer (breath-actuated versus conventional continuous-output): Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol used in both devices. |
| FG001 | Conventional Continuous-ouput Nebulizer | Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer Nebulizer (breath-actuated versus conventional continuous-output): Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol used in both devices. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Breath-Actuated Nebulizer | Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Nebulizer (breath-actuated versus conventional continuous-output): Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol used in both devices. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Rate of Admission to Hospital for Asthma Exacerbation | Number (and percentage) of children in each study group requiring admission to the hospital for asthma exacerbation/status asthmaticus from the Pediatric Emergency Department (as opposed to being discharged to home) | Posted | Count of Participants | Participants | 24 hours (whether patient is admitted after presenting to emergency department for asthma or discharged home) |
|
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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 | Breath-Actuated Nebulizer | Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Nebulizer (breath-actuated versus conventional continuous-output): Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol are used in both devices. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jerri Rose | University Hospitals Cleveland Medical Center | 216-844-7147 | jerri.rose@uhhospitals.org |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D009330 | Nebulizers and Vaporizers |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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|
Percentage of patients (or caregivers of younger children) who "agreed" or "strongly agreed" on a brief survey (using a 5-point Likert scale) that they would feel comfortable with using the same nebulizer device to take asthma treatments in the future. Likert-type scale was used, on which score of 1=strongly disagree, 2=disagree, 3=neither agree nor disagree (or unsure), 4=agree, and 5=strongly agree. |
| within time frame of emergency department stay (up to 400 minutes from initial presentation to pediatric ED) |
| Difficulty (if Any) Encountered by Patients With Using Assigned Nebulizer Device | number of children who had difficulty using assigned nebulizer device during the timeframe of the ED visit during which the study nebulizer was used. Timeframe for outcome measure was length of single emergency department visit, up to 400 minutes. |
| BG001 | Conventional Continuous-ouput Nebulizer | Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer Nebulizer (breath-actuated versus conventional continuous-output): Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol used in both devices. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Conventional Continuous-ouput Nebulizer | Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer Nebulizer (breath-actuated versus conventional continuous-output): Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol used in both devices. |
|
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| Secondary | Length of Stay in the Emergency Department After Presenting for Asthma Exacerbation | Length of stay in the emergency department measured in minutes; up to 400 minutes measured | Posted | Mean | Full Range | minutes | only measures length of stay in emergency department on date of presentation |
|
|
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| Secondary | Patient's Satisfaction With Using Assigned Nebulizer (as Assessed by Brief Survey) | Percentage of patients (or caregivers of younger children) who "agreed" or "strongly agreed" on a brief survey (using a 5-point Likert scale) that they would feel comfortable with using the same nebulizer device to take asthma treatments in the future. Likert-type scale was used, on which score of 1=strongly disagree, 2=disagree, 3=neither agree nor disagree (or unsure), 4=agree, and 5=strongly agree. | Posted | Count of Participants | Participants | within time frame of emergency department stay (up to 400 minutes from initial presentation to pediatric ED) |
|
|
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| Secondary | Difficulty (if Any) Encountered by Patients With Using Assigned Nebulizer Device | Posted | Count of Participants | Participants | number of children who had difficulty using assigned nebulizer device during the timeframe of the ED visit during which the study nebulizer was used. Timeframe for outcome measure was length of single emergency department visit, up to 400 minutes. |
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| 0 |
| 90 |
| 0 |
| 90 |
| 0 |
| 90 |
| EG001 | Conventional Continuous-ouput Nebulizer | Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer Nebulizer (breath-actuated versus conventional continuous-output): Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol are used in both devices. | 0 | 90 | 0 | 90 | 0 | 90 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |