Trial Outcomes & Findings for Comparison of Nebulizers in ED in Pediatric Asthma Patients (NCT NCT01951378)
NCT ID: NCT01951378
Last Updated: 2021-04-08
Results Overview
The primary endpoint will be mean ED LOS difference between the groups. Using historical data as a guide, we calculated a baseline LOS mean for discharged patients of 181 minutes, and standard deviation (SD) of 83 minutes. For this reason, an interim analysis will be conducted in order to assess a pilot sample for the purpose of estimating these values. 25 subjects in each arm (50 subjects total) will be enrolled during the initial phase of the study. This early phase interim analysis is not powered to test for differences between the groups, but establish pilot-phase findings that can be used for more accurate sample size calculation. However, the primary outcome of ED LOS will then be tested to determine the difference between study arms, using the non-parametric Mann-Whitney U test due to the likely skewed-nature of the distribution of ED LOS values for the purpose of establishing an estimate of effect size in the initial enrollment phase.
TERMINATED
PHASE4
40 participants
1 year
2021-04-08
Participant Flow
Participant milestones
| Measure |
Hudson RCI® Nebulizer
Patients randomized to the standard arm will receive treatments as dictated by our standard ED asthma pathway (Fig. 1). All treatments will be administered with our standard ED nebulizer, the Hudson RCI® Up-Draft® Neb-U-Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ), and a simple mask (Hudson RCI®, Teleflex Medical®, Research Triangle Park, NJ).
Hudson RCI® nebulizer: After the first hour of treatment, patients in the standard arm will receive a repeat assessment, including all of the measurements collected at baseline as well as reported side effects. Those patients who score PAS 0-2 will then be discharged home, after an optional observation period, as per the pathway. Those who score PAS \> 2 will receive a second treatment. At the end of the second treatment patients will again be re-assessed, and repeat measurements obtained. At that time, depending on the patient's PAS score, he/she will be dispositioned to home, the floor, the pulmonary high acuity unit (PHA
|
NebuTech® HDN® Nebulizer
Patients randomized to the NebuTech® arm will receive treatments as dictated by our trial pathway, referred to as the "rapid Albuterol/Proventil delivery pathway" (Fig. 2). All nebulizations in this arm will be administered via the Breath-Enhanced High Density Jet Nebulizer, NebuTech® HighDensityNebulizer®,(Salter Labs®, Arvin, CA). Respiratory Therapists (RT) will attempt to deliver all treatments with a mouthpiece, as that has been shown to be the most efficient and reliable mode of aerosol delivery for most children 31, 32. If the Respiratory Therapist feels that the child will not or cannot effectively use a mouthpiece, a mask will be used.
NebuTech® HDN® nebulizer: All treatments in the NebuTech® arm will be given at a standard dilution of 5 ml (diluted with normal saline to a total volume of 5 ml as per the manufacturer's recommendation). Patients in this arm will receive up to four treatments with parameters measured after each treatment, similar to the control arm. Patient
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
17
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
23
|
17
|
Reasons for withdrawal
| Measure |
Hudson RCI® Nebulizer
Patients randomized to the standard arm will receive treatments as dictated by our standard ED asthma pathway (Fig. 1). All treatments will be administered with our standard ED nebulizer, the Hudson RCI® Up-Draft® Neb-U-Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ), and a simple mask (Hudson RCI®, Teleflex Medical®, Research Triangle Park, NJ).
Hudson RCI® nebulizer: After the first hour of treatment, patients in the standard arm will receive a repeat assessment, including all of the measurements collected at baseline as well as reported side effects. Those patients who score PAS 0-2 will then be discharged home, after an optional observation period, as per the pathway. Those who score PAS \> 2 will receive a second treatment. At the end of the second treatment patients will again be re-assessed, and repeat measurements obtained. At that time, depending on the patient's PAS score, he/she will be dispositioned to home, the floor, the pulmonary high acuity unit (PHA
|
NebuTech® HDN® Nebulizer
Patients randomized to the NebuTech® arm will receive treatments as dictated by our trial pathway, referred to as the "rapid Albuterol/Proventil delivery pathway" (Fig. 2). All nebulizations in this arm will be administered via the Breath-Enhanced High Density Jet Nebulizer, NebuTech® HighDensityNebulizer®,(Salter Labs®, Arvin, CA). Respiratory Therapists (RT) will attempt to deliver all treatments with a mouthpiece, as that has been shown to be the most efficient and reliable mode of aerosol delivery for most children 31, 32. If the Respiratory Therapist feels that the child will not or cannot effectively use a mouthpiece, a mask will be used.
NebuTech® HDN® nebulizer: All treatments in the NebuTech® arm will be given at a standard dilution of 5 ml (diluted with normal saline to a total volume of 5 ml as per the manufacturer's recommendation). Patients in this arm will receive up to four treatments with parameters measured after each treatment, similar to the control arm. Patient
|
|---|---|---|
|
Overall Study
Study Terminated-Not completed
|
23
|
17
|
Baseline Characteristics
Comparison of Nebulizers in ED in Pediatric Asthma Patients
Baseline characteristics by cohort
| Measure |
Hudson RCI® Nebulizer
n=23 Participants
Patients randomized to standard arm receives treatments per standard ED asthma pathway. Treatments administered with standard ED nebulizer, Hudson RCI® Up-Draft® Neb-U-Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ), and a simple mask (Hudson RCI®, Teleflex Medical®, Research Triangle Park, NJ).
Hudson RCI® nebulizer: After 1 hour, patients in standard arm receive another assessment, with all baseline measurements and reported side effects. Patients who score PAS 0-2 will be discharged, after optional observation period, per pathway. Those who score PAS \> 2 receive second treatment, then re-assessed, and measurements repeated. Then, depending on PAS score, he/she will be sent, the floor, the pulmonary high acuity unit (PHAU), or PICU.
Albuterol: Subjects may begin treatment before consent and may receive 2.5 mg Albuterol/Proventil treatments given with standard nebulizer \<3 times as needed and may change over to study randomized device once consented to either arm.
|
NebuTech® HDN® Nebulizer
n=17 Participants
Randomized patients receive treatments per "rapid Albuterol/Proventil delivery pathway". Nebulizations given via Breath-Enhanced High Density Jet Nebulizer, NebuTech® HighDensityNebulizer®,(Salter Labs®, Arvin, CA). If child will not or cannot use mouthpiece, a mask will be used.
NebuTech® HDN® nebulizer: Treatments are dilution of 5 ml. Patients receive \<4 treatments with measurements after each. Patients who complete 4 treatments will be dispositioned based on PAS score. Subjects may begin treatment before consent and may receive 2.5 mg Albuterol/Proventil treatments via standard nebulizer \<3 times as needed and may change to study randomized device once consented to either arm.
Albuterol: Subjects may start treatment before consent and may receives 2.5 mg Albuterol/Proventil given with standard nebulizer \<3 times as needed and may change over to study randomized device once consented to either arm.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
11 years
STANDARD_DEVIATION 5 • n=5 Participants
|
9 years
STANDARD_DEVIATION 5 • n=7 Participants
|
10 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
17 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: No data are available for this study as the PI has left the institution and no study team member is present. The local IRB closed and was replaced in July 2017 by the University of Texas. Sincere efforts were made to obtain the data for reporting, however, no data are available
The primary endpoint will be mean ED LOS difference between the groups. Using historical data as a guide, we calculated a baseline LOS mean for discharged patients of 181 minutes, and standard deviation (SD) of 83 minutes. For this reason, an interim analysis will be conducted in order to assess a pilot sample for the purpose of estimating these values. 25 subjects in each arm (50 subjects total) will be enrolled during the initial phase of the study. This early phase interim analysis is not powered to test for differences between the groups, but establish pilot-phase findings that can be used for more accurate sample size calculation. However, the primary outcome of ED LOS will then be tested to determine the difference between study arms, using the non-parametric Mann-Whitney U test due to the likely skewed-nature of the distribution of ED LOS values for the purpose of establishing an estimate of effect size in the initial enrollment phase.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: No data are available for this study as the PI has left the institution and no study team member is present. The local IRB closed and was replaced in July 2017 by the University of Texas. Sincere efforts were made to obtain the data for reporting, however, no data are available
Baseline characteristics (demographics, history, and clinical characteristics of presentation) of subjects in each treatment arm will be summarized in a table. These descriptive characteristics will be compared between arms using standard t-test or a non-parametric alternative for linear values (eg, age) and chi-squared tests for binomial or categorical values (eg, gender) with p-values reported in the summary table.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearBaseline characteristics (demographics, history, and clinical characteristics of presentation) of subjects in each treatment arm will be summarized in a table. These descriptive characteristics will be compared between arms using standard t-test or a non-parametric alternative for linear values (eg, age) and chi-squared tests for binomial or categorical values (eg, gender) with p-values reported in the summary table.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearBaseline characteristics (demographics, history, and clinical characteristics of presentation) of subjects in each treatment arm will be summarized in a table. These descriptive characteristics will be compared between arms using standard t-test or a non-parametric alternative for linear values (eg, age) and chi-squared tests for binomial or categorical values (eg, gender) with p-values reported in the summary table.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearBaseline characteristics (demographics, history, and clinical characteristics of presentation) of subjects in each treatment arm will be summarized in a table. These descriptive characteristics will be compared between arms using standard t-test or a non-parametric alternative for linear values (eg, age) and chi-squared tests for binomial or categorical values (eg, gender) with p-values reported in the summary table
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearBaseline characteristics (demographics, history, and clinical characteristics of presentation) of subjects in each treatment arm will be summarized in a table. These descriptive characteristics will be compared between arms using standard t-test or a non-parametric alternative for linear values (eg, age) and chi-squared tests for binomial or categorical values (eg, gender) with p-values reported in the summary table.
Outcome measures
Outcome data not reported
Adverse Events
Hudson RCI® Nebulizer
NebuTech® HDN® Nebulizer
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place