Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Percent of participants enrolled |
Percent of participants randomized divided by the percent of participants approached. |
12 months |
|
Secondary |
Mean Change in Pediatric Asthma Severity Score (PASS) |
The Pediatric Asthma Severity Score (PASS) is a validated tool to measure asthma severity in pediatric patients. It is a scale that ranges from 5-15 with scores 8-11 indicating moderate asthma exacerbation and scores greater than 11 indicating severe exacerbation. The score has also been shown to be responsive to asthma therapies, with a decrease in score being indicative of improvement. We will measure the PASS score at the start of the trial, at hour 1 and at the completion of the trial at hour 2. We will compare changes in PASS scores across all three groups. |
Baseline to 2 hours |
|
Secondary |
Mean Change in Respiratory Rate |
We will record the mean change in respiratory rate during the two our study period across all 3 study groups. |
Baseline to 2 hours |
|
Secondary |
Mean Total Duration of Continuous Albuterol |
We will follow children longitudinally until hospital discharge and record the total duration of hours patients spent on continuous albuterol. |
Approximately 3 days |
|
Secondary |
Percentage of Children with Escalation of Respiratory Support |
We will record the percentage of children requiring an increase in respiratory support (defined as escalation of support to HFNC of any flow rate, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BPAP), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO)) either during the 2-hour trial period, immediately upon completion, or within the first 24 hours of study enrollment time. |
1 day |
|
Secondary |
Mean Total Duration of Respiratory Support |
We will follow children longitudinally until hospital discharge and record the total duration of hours patients spent on any respiratory support modality including COT, HFNC, noninvasive ventilation (NIV), invasive ventilation (IMV), or extracorporeal membrane oxygenation (ECMO). |
Until hospital discharge, approximately 5 days |
|
Secondary |
Percentage of Participants placed on Adjunct Asthma Therapies |
We will describe how many children in each group were placed on adjunct asthma therapies including magnesium, heliox, leukotriene receptor antagonists, intravenous beta agonist therapies, and methylxantines either before, during, or after study period. |
Until hospital discharge, approximately 5 days |
|
Secondary |
Percentage of Participants who needed Sedation |
We will record how many children in each group required sedation and/or anxiolytics while on their respiratory support modality either during the trial or afterwards. |
Until hospital discharge, approximately 5 days |
|
Secondary |
Percentage of Participants on Antibiotics |
We will record how many children completed full 5-7 day courses of antibiotics for bacterial pneumonia concurrent with their asthma exacerbation. |
Until hospital discharge, approximately 5 days |
|
Secondary |
Mean PICU Length of Stay (LOS) |
We will follow children longitudinally to record the amount of time children were admitted to the PICU for. |
Until hospital discharge, approximately 3 days |
|
Secondary |
Mean Hospital Length of Stay (LOS) |
We will follow children longitudinally to record the amount of time children were admitted to the hospital for. |
Until hospital discharge, approximately 7 days |
|