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Asthma is a leading cause of emergency department (ED) visits for children. A novel way of treating asthma is the use of positive expiratory pressure (PEP). Positive expiratory pressure works by creating pressure in the lungs to keep airways open and to clear mucus from the lungs. PEP is already used in the treatment of asthma at the investigators institution, but studies evaluating the efficacy of PEP therapy in asthma exacerbations do not exist. This study plans to learn more about the use of PEP therapy in the treatment of asthma exacerbations in children in the emergency department. Specifically, the study aims to evaluate if PEP therapy reduces the severity of asthma exacerbations in children and if it reduces the need for additional therapies and admission to the hospital. This study will be a randomized control trial comparing children who receive standard therapy to those who receive standard therapy plus PEP therapy in the treatment of asthma exacerbations. Children age 2 to 18 years presenting to the ED with moderate to severe asthma exacerbations will be included in the study. Reduction in clinical asthma severity will be measured by change in the Pulmonary Asthma Score (the respiratory severity score used at the investigators institution). The need for additional therapies and hospitalization will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EzPAP | Experimental | Patients randomized to the EzPAP arm will receive first-line therapies and PEP therapy via EzPAP. All patients will receive 4 cycles with 12 breaths per cycle. 4 cycles is considered one time administration. |
|
| Standard care | Sham Comparator | Patients randomized to the control arm will receive first-line therapies and standard therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EzPAP | Drug |
|
| |
| Standard Care |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pulmonary Asthma Score (PAS) | The primary outcome was the change in asthma severity as determined by change in Pulmonary Asthma Score (PAS) before and after administration of intervention (or control). The same trained, blinded physician assessor, who was not involved in the care of the patient, assessed PAS scores for study subjects before intervention (or control), and 15 minutes after completion of administration. The PAS is a pediatric asthma severity scoring system adapted from previously validated scores, and includes measures of respiratory rate, oxygen saturation, auscultory findings, retractions, and dyspnea. Values from each category are summed producing a total score between 5 and 15. Total scores < 7 correspond with mild asthma exacerbations, while scores ≥ 7 and < 12 indicate moderate asthma, and scores ≥12 to 15 indicate severe asthma. The primary outcome was determined by subtracting the post-intervention score from the pre-intervention score. | 0-30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Requiring Second Line Therapies Including Continuous Albuterol, Subcutaneous Terbutaline, IV Magnesium and Supplemental Oxygen After Administration of Intervention or Control | Second line therapies include: continuous albuterol, intravenous magnesium sulfate, subcutaneous or intravenous terbutaline, non-invasive ventilation (BiPAP or CPAP), and supplemental oxygen. The need for these second line therapies will be assessed by the child's treating team in the Emergency Department. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nidhya Navanandan, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital Colorado | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28284473 | Derived | Navanandan N, Federico M, Mistry RD. Positive Expiratory Pressure for the Treatment of Acute Asthma Exacerbations: A Randomized Controlled Trial. J Pediatr. 2017 Jun;185:149-154.e2. doi: 10.1016/j.jpeds.2017.02.032. Epub 2017 Mar 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | EzPAP | Patients randomized to the EzPAP arm will receive first-line therapies and PEP therapy via EzPAP. All patients will receive 4 cycles with 12 breaths per cycle. EzPAP |
| FG001 | Standard Care | Patients randomized to the control arm will receive first-line therapies and standard therapy. Standard Care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EzPAP | Patients randomized to the EzPAP arm will receive first-line therapies and PEP therapy via EzPAP. All patients will receive 4 cycles with 12 breaths per cycle. EzPAP |
| BG001 | Standard Care |
| 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 | Change in Pulmonary Asthma Score (PAS) | The primary outcome was the change in asthma severity as determined by change in Pulmonary Asthma Score (PAS) before and after administration of intervention (or control). The same trained, blinded physician assessor, who was not involved in the care of the patient, assessed PAS scores for study subjects before intervention (or control), and 15 minutes after completion of administration. The PAS is a pediatric asthma severity scoring system adapted from previously validated scores, and includes measures of respiratory rate, oxygen saturation, auscultory findings, retractions, and dyspnea. Values from each category are summed producing a total score between 5 and 15. Total scores < 7 correspond with mild asthma exacerbations, while scores ≥ 7 and < 12 indicate moderate asthma, and scores ≥12 to 15 indicate severe asthma. The primary outcome was determined by subtracting the post-intervention score from the pre-intervention score. | 2 patients in EzPAP group were excluded from analysis due to protocol error and missing data. | Posted | Mean | Standard Deviation | mean PAS score | 0-30 minutes |
|
Adverse events were monitored and collected during the total ED course.
The definition of adverse event does not differ from the clinicaltrials.gov definitions.
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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 | EzPAP | Patients randomized to the EzPAP arm will receive first-line therapies and PEP therapy via EzPAP. All patients will receive 4 cycles with 12 breaths per cycle. EzPAP |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
Specific PEP parameters were used that may not have been ideal for the study population. PEP was administered only once. 4 cycles is considered a one time administration. Subsequent administrations were not performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nidhya Navanandan, MD | University Colorado School of Medicine, Chidren's Hospital Colorado | 847-636-0817 | nidhya.navanandan@childrenscolorado.org |
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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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| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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| Other |
|
| participants will be followed for the duration of ED stay, an expected average of 6-8 hours |
| Rate of Inpatient Hospitalization | Number of patients in each group requiring hospital admission | After intervention or control and until follow-up phone call 72 hours after disposition |
Patients randomized to the control arm will receive first-line therapies and standard therapy.
Standard Care
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | EzPAP | Patients randomized to the EzPAP arm will receive first-line therapies and PEP therapy via EzPAP. All patients will receive 4 cycles with 12 breaths per cycle. EzPAP |
| OG001 | Standard Care | Patients randomized to the control arm will receive first-line therapies and standard therapy. Standard Care |
|
|
| Secondary | Number of Participants Requiring Second Line Therapies Including Continuous Albuterol, Subcutaneous Terbutaline, IV Magnesium and Supplemental Oxygen After Administration of Intervention or Control | Second line therapies include: continuous albuterol, intravenous magnesium sulfate, subcutaneous or intravenous terbutaline, non-invasive ventilation (BiPAP or CPAP), and supplemental oxygen. The need for these second line therapies will be assessed by the child's treating team in the Emergency Department. | 2 subjects excluded from analysis due to missing data | Posted | Count of Participants | Participants | participants will be followed for the duration of ED stay, an expected average of 6-8 hours |
|
|
|
| Secondary | Rate of Inpatient Hospitalization | Number of patients in each group requiring hospital admission | 2 patients excluded due to missing data and protocol error | Posted | Count of Participants | Participants | After intervention or control and until follow-up phone call 72 hours after disposition |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 3 |
| 26 |
| EG001 | Standard Care | Patients randomized to the control arm will receive first-line therapies and standard therapy. Standard Care | 0 | 26 | 0 | 26 | 0 | 26 |
| Light-headedness | Nervous system disorders | Systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D019984 |
| Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| Intravenous magnesium |
|
| Supplemental oxygen |
|