Asthma
Conditions
Keywords
Asthma, Pediatric, Emergency department, Nebulizer
Brief summary
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.
Interventions
DEVICENebulizer (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.
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* children 1-17 years old with known history of asthma * children must be presenting to the emergency department for treatment of acute asthma * children must qualify to be treated for acute asthma according to an existing standardized asthma care algorithm
Exclusion criteria
* concomitant chronic respiratory or cardiac disease such as cystic fibrosis, congenital heart disease, or bronchopulmonary dysplasia * no prior history of asthma * pregnancy * reported history of drug allergy to albuterol or ipratropium bromide * previous participation in the study within the preceding three weeks * vital sign instability/need for immediate emergency intervention to prevent clinical deterioration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Admission to Hospital for Asthma Exacerbation | 24 hours (whether patient is admitted after presenting to emergency department for asthma or discharged home) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay in the Emergency Department After Presenting for Asthma Exacerbation | only measures length of stay in emergency department on date of presentation | Length of stay in the emergency department measured in minutes; up to 400 minutes measured |
| Patient's Satisfaction With Using Assigned Nebulizer (as Assessed by Brief Survey) | within time frame of emergency department stay (up to 400 minutes from initial presentation to pediatric ED) | 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. |
| 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. | — |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
180 participants were enrolled in the study. No enrolled participants were excluded from the study before assignment to groups.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 90 |
| 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. | 90 |
| Total | 180 |
Baseline characteristics
| Characteristic | Conventional Continuous-ouput Nebulizer | Total | Breath-Actuated Nebulizer |
|---|---|---|---|
| Age, Categorical <=18 years | 90 Participants | 180 Participants | 90 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 | 6.7 years | 6.65 years | 6.6 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 90 participants | 180 participants | 90 participants |
| Sex: Female, Male Female | 44 Participants | 90 Participants | 46 Participants |
| Sex: Female, Male Male | 46 Participants | 90 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 0 / 90 |
| other Total, other adverse events | 0 / 90 | 0 / 90 |
| serious Total, serious adverse events | 0 / 90 | 0 / 90 |
Outcome results
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)
Time frame: 24 hours (whether patient is admitted after presenting to emergency department for asthma or discharged home)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Breath-Actuated Nebulizer | Rate of Admission to Hospital for Asthma Exacerbation | 33 Participants |
| Conventional Continuous-ouput Nebulizer | Rate of Admission to Hospital for Asthma Exacerbation | 44 Participants |
Secondary
Difficulty (if Any) Encountered by Patients With Using Assigned Nebulizer Device
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Breath-Actuated Nebulizer | Difficulty (if Any) Encountered by Patients With Using Assigned Nebulizer Device | 0 Participants |
| Conventional Continuous-ouput Nebulizer | Difficulty (if Any) Encountered by Patients With Using Assigned Nebulizer Device | 0 Participants |
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
Time frame: only measures length of stay in emergency department on date of presentation
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Breath-Actuated Nebulizer | Length of Stay in the Emergency Department After Presenting for Asthma Exacerbation | 162 minutes |
| Conventional Continuous-ouput Nebulizer | Length of Stay in the Emergency Department After Presenting for Asthma Exacerbation | 178 minutes |
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.
Time frame: within time frame of emergency department stay (up to 400 minutes from initial presentation to pediatric ED)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Breath-Actuated Nebulizer | Patient's Satisfaction With Using Assigned Nebulizer (as Assessed by Brief Survey) | 76 Participants |
| Conventional Continuous-ouput Nebulizer | Patient's Satisfaction With Using Assigned Nebulizer (as Assessed by Brief Survey) | 55 Participants |