Comparison of Breath-Enhanced and T-Piece Nebulizers in Children With Acute Asthma
Sponsor
Seton Healthcare Family (Other)
Overall Status
Completed
CT.gov ID
NCT02566902
Collaborator
University of Texas (Other)
118
1
2
21
5.6
Study Details
Study Description
Brief Summary
This is a blinded observer randomized controlled trial comparing two nebulizer devices. The objective of this study is to evaluate the efficacy of two different nebulizers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The investigators hypothesize that albuterol delivered with a breath-enhanced nebulizer will lead to statistically greater improvement in FEV1 when compared to an equivalent dose delivered via a standard t-piece nebulizer. The primary aim will be to study changes in forced expiratory volume in one second (FEV1) in patients presenting to an urban pediatric emergency department with a moderate to severe acute asthma exacerbation when utilizing these two nebulizers. Secondary aims will include evaluation of hospital admission rates, emergency department (ED) length of stay (LOS), changes in asthma severity scores, vital sign changes, medication side effects, and total quantity of albuterol given in the ED. A distal aim of the study will be to perform a cost analysis; though the investigators will likely need further clinical trials utilizing multiple dose administration in order to accurately analyze cost.
Study Design
Study Type:
Interventional
Actual Enrollment
:
118 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Comparison of Breath-Enhanced and T-Piece Nebulizers in Children With Acute Asthma
Study Start Date
:
Oct 1, 2015
Actual Primary Completion Date
:
Jun 30, 2017
Actual Study Completion Date
:
Jun 30, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: T-piece Nebulizer Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. |
Device: T-Piece Nebulizer
Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ)
Drug: Albuterol
One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes.
Other Names:
Procedure: Pre-Treatment Spirometry Measurement
Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer.
Procedure: Post-Treatment Spirometry Measurement
Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer.
|
| Experimental: Breath-Enhanced Nebulizer Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. |
Device: Breath-Enhanced Nebulizer
Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA)
Drug: Albuterol
One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes.
Other Names:
Procedure: Pre-Treatment Spirometry Measurement
Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer.
Procedure: Post-Treatment Spirometry Measurement
Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer.
|
Outcome Measures
Primary Outcome Measures
- Change in FEV1 (% Predicted) [10 minutes]
Pre-treatment spirometry measurement assessed at the time of study enrollment. Post-treatment spirometry measurement assessed following the administration of one time 5mg nebulized albuterol sulfate treatment. Assessments taken at baseline (prior to albuterol therapy) and 10 min post-treatment. Change in FEV1 calculated as post-treatment FEV1 minus pre-treatment FEV1
Secondary Outcome Measures
- Change in PAS Score (Points on a Scale) [10 minutes]
Based on examination and auscultation of lungs prior to and immediately following albuterol administration. PAS score is on a scale of 0-10 which is a sum of five separate sub-scores each on a scale of 0-2. The five sub-scores are: Respiratory rate (6-12yr/>12yr): <=26/23 (0), 27-30/24-27 (1), >31/28 (2) Oxygenation: >95% (0), 90-95 (1), <90 (2) Auscultation: clear/end expiratory wheeze (0), expiratory wheeze (1), biphasic wheeze/diminished (2) Work of Breathing (accessory muscles): <= 1 (0), 2 (1), >=3 (2) Dyspnea: Full sentences (0), Partial sentences (1), Single words (2) Pre-treatment assessment at the time of study enrollment. Post-treatment assessment following the administration of one time 5mg nebulized albuterol sulfate treatment. Assessments taken at baseline (prior to albuterol therapy) and 10 min post-treatment. Change in PAS calculated as post-treatment PAS minus pre-treatment PAS.
- Change in PASS Score (Points on a Scale) [10 minutes]
Determined by examination and auscultation of lungs to prior to and immediately following albuterol administration. PASS is a total score on a scale of 0-6 which is calculated as a sum of three sub-scores, each on a scale of 0-2. The sub-scores are: Wheezing: None or Mild (0), Moderate (1), Severe wheezing or absent wheezing due to poor air exchange (2) Work of breathing (accessory muscle use or retractions): None or mild (0), Moderate (1), Severe (2) Prolonged expiration: Normal or mildly prolonged (0), moderately prolonged (1), severely prolonged (2) Pre-treatment assessment at the time of study enrollment. Post-treatment assessment following the administration of one time 5mg nebulized albuterol sulfate treatment. Assessments taken at baseline (prior to albuterol therapy) and 10 min post-treatment. Change in PASS calculated as post-treatment PASS minus pre-treatment PASS.
- Percentage of Patients Requiring Inpatient Hospital Admission (% of Subjects) [Up to 24 hours]
Admission rate to inpatient hospital will be assessed at the time of Emergency Department disposition which will be approximately 3 hours, but will be assessed up to 24 hours depending on duration of ED stay.
- Emergency Department Length of Stay (Minutes) [Up to 24 hours]
Total length of stay will be assessed at the time of Emergency Department disposition which will be approximately 3 hours, but will be assessed up to 24 hours depending on duration of ED stay.
- Percentage of Patients Experiencing Medication Side Effects (%) [10 minutes]
Subjects and parents/guardians will be asked whether subjects experienced nausea, vomiting, palpitations, headache, dizziness either during (assessed by non-blinded personnel) or following treatment (assessed by blinded personnel during post-treatment assessment). Subject and parent/guardian will also be asked if any "other" side effects were experienced.
- Total Quantity of Albuterol Given in the Emergency Department (mg) [up to 24 hours]
Cumulative dose of albuterol in mg will be assessed at the time of Emergency Department disposition which will be approximately 3 hours, but will be assessed up to 24 hours depending on duration of ED stay.
- Change Respiratory Rate (Breaths Per Minute) [10 minutes]
Respiratory rate will be measured by observation and auscultation over 30 seconds prior to and immediately following albuterol administration Pre-treatment assessment at the time of study enrollment. Post-treatment assessment following the administration of one time 5mg nebulized albuterol sulfate treatment. Assessments taken at baseline (prior to albuterol therapy) and 10 min post-treatment. Change in respiratory rate calculated as post-treatment respiratory rate minus pre-treatment respiratory rate.
- Change in Heart Rate (Beats Per Minute) [10 minutes]
Blinded research personnel will assess subject's heart rate by auscultation and/or pulse palpation prior to and immediately following albuterol administration. Pre-treatment assessment at the time of study enrollment. Post-treatment assessment following the administration of one time 5mg nebulized albuterol sulfate treatment. Assessments taken at baseline (prior to albuterol therapy) and 10 min post-treatment. Change in heart rate calculated as post-treatment heart rate minus pre-treatment heart rate.
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Years
to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age ≥ 6 years and < 18 years
-
History of physician diagnosed asthma
-
Presenting to ED with breathing difficulty or cough
-
Initial FEV1 25%-70% predicted
-
Parent or guardian speaks English or Spanish.
Exclusion Criteria:
-
Pediatric Asthma Score of 0
-
Pregnancy or breast-feeding
-
Immediate resuscitation required
-
Chronic lung disease (other than asthma)
-
Congenital heart disease
-
Neuromuscular disease
-
Suspected intrathoracic foreign body
-
Allergy or other contraindication to study medication
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dell Children's Medical Center, Emergency Department | Austin | Texas | United States | 78723 |
Sponsors and Collaborators
- Seton Healthcare Family
- University of Texas
Investigators
- Principal Investigator: Matthew Wilkinson, MD, Seton Healthcare Family
Study Documents (Full-Text)
More Information
Additional Information:
Publications
- Aggarwal AN, Gupta D, Jindal SK. The relationship between FEV1 and peak expiratory flow in patients with airways obstruction is poor. Chest. 2006 Nov;130(5):1454-61. Erratum in: Chest. 2007 Aug;132(2):738.
- Barr RG, Stemple KJ, Mesia-Vela S, Basner RC, Derk SJ, Henneberger PK, Milton DK, Taveras B. Reproducibility and validity of a handheld spirometer. Respir Care. 2008 Apr;53(4):433-41.
- Cates CJ, Welsh EJ, Rowe BH. Holding chambers (spacers) versus nebulisers for beta-agonist treatment of acute asthma. Cochrane Database Syst Rev. 2013 Sep 13;(9):CD000052. doi: 10.1002/14651858.CD000052.pub3. Review.
- Colacone A, Afilalo M, Wolkove N, Kreisman H. A comparison of albuterol administered by metered dose inhaler (and holding chamber) or wet nebulizer in acute asthma. Chest. 1993 Sep;104(3):835-41.
- Devadason SG, Everard ML, Linto JM, Le Souëf PN. Comparison of drug delivery from conventional versus "Venturi" nebulizers. Eur Respir J. 1997 Nov;10(11):2479-83.
- Eid N, Yandell B, Howell L, Eddy M, Sheikh S. Can peak expiratory flow predict airflow obstruction in children with asthma? Pediatrics. 2000 Feb;105(2):354-8.
- Gorelick MH, Stevens MW, Schultz T, Scribano PV. Difficulty in obtaining peak expiratory flow measurements in children with acute asthma. Pediatr Emerg Care. 2004 Jan;20(1):22-6.
- Gorelick MH, Stevens MW, Schultz TR, Scribano PV. Performance of a novel clinical score, the Pediatric Asthma Severity Score (PASS), in the evaluation of acute asthma. Acad Emerg Med. 2004 Jan;11(1):10-8.
- Hess DR. Aerosol delivery devices in the treatment of asthma. Respir Care. 2008 Jun;53(6):699-723; discussion 723-5.
- Ho SL, Kwong WT, O'Drowsky L, Coates AL. Evaluation of four breath-enhanced nebulizers for home use. J Aerosol Med. 2001 Winter;14(4):467-75.
- Lin YZ, Huang FY. Comparison of breath-actuated and conventional constant-flow jet nebulizers in treating acute asthmatic children. Acta Paediatr Taiwan. 2004 Mar-Apr;45(2):73-6.
- Mandelberg A, Tsehori S, Houri S, Gilad E, Morag B, Priel IE. Is nebulized aerosol treatment necessary in the pediatric emergency department? Chest. 2000 May;117(5):1309-13.
- Mason N, Roberts N, Yard N, Partridge MR. Nebulisers or spacers for the administration of bronchodilators to those with asthma attending emergency departments? Respir Med. 2008 Jul;102(7):993-8. doi: 10.1016/j.rmed.2008.02.009. Epub 2008 Apr 18.
- Newman SP, Pitcairn GR, Hooper G, Knoch M. Efficient drug delivery to the lungs from a continuously operated open-vent nebulizer and low pressure compressor system. Eur Respir J. 1994 Jun;7(6):1177-81.
- Newnham DM, Lipworth BJ. Nebuliser performance, pharmacokinetics, airways and systemic effects of salbutamol given via a novel nebuliser delivery system ("Ventstream"). Thorax. 1994 Aug;49(8):762-70.
- Osmond MH, Gazarian M, Henry RL, Clifford TJ, Tetzlaff J; PERC Spacer Study Group. Barriers to metered-dose inhaler/spacer use in Canadian pediatric emergency departments: a national survey. Acad Emerg Med. 2007 Nov;14(11):1106-13. Epub 2007 Aug 15.
- Qureshi F, Pestian J, Davis P, Zaritsky A. Effect of nebulized ipratropium on the hospitalization rates of children with asthma. N Engl J Med. 1998 Oct 8;339(15):1030-5.
- Rubin BK, Fink JB. The delivery of inhaled medication to the young child. Pediatr Clin North Am. 2003 Jun;50(3):717-31. Review.
- Sabato K, Ward P, Hawk W, Gildengorin V, Asselin JM. Randomized controlled trial of a breath-actuated nebulizer in pediatric asthma patients in the emergency department. Respir Care. 2011 Jun;56(6):761-70. doi: 10.4187/respcare.00142. Epub 2011 Feb 11.
- Schneider WV, Bulloch B, Wilkinson M, Garcia-Filion P, Keahey L, Hostetler M. Utility of portable spirometry in a pediatric emergency department in children with acute exacerbation of asthma. J Asthma. 2011 Apr;48(3):248-52. doi: 10.3109/02770903.2011.555036. Epub 2011 Feb 21.
- Schuh S, Johnson DW, Stephens D, Callahan S, Winders P, Canny GJ. Comparison of albuterol delivered by a metered dose inhaler with spacer versus a nebulizer in children with mild acute asthma. J Pediatr. 1999 Jul;135(1):22-7.
- Scott SD, Osmond MH, O'Leary KA, Graham ID, Grimshaw J, Klassen T; Pediatric Emergency Research Canada (PERC) MDI/spacer Study Group. Barriers and supports to implementation of MDI/spacer use in nine Canadian pediatric emergency departments: a qualitative study. Implement Sci. 2009 Oct 13;4:65. doi: 10.1186/1748-5908-4-65.
- Standardization of Spirometry, 1994 Update. American Thoracic Society. Am J Respir Crit Care Med. 1995 Sep;152(3):1107-36.
- Tien I, Dorfman D, Kastner B, Bauchner H. Metered-dose inhaler: the emergency department orphan. Arch Pediatr Adolesc Med. 2001 Dec;155(12):1335-9.
- Wilkinson M, Bulloch B, Garcia-Filion P, Keahey L. Efficacy of racemic albuterol versus levalbuterol used as a continuous nebulization for the treatment of acute asthma exacerbations: a randomized, double-blind, clinical trial. J Asthma. 2011 Mar;48(2):188-93. doi: 10.3109/02770903.2011.554939. Epub 2011 Jan 29.
Responsible Party:
Seton Healthcare Family
ClinicalTrials.gov Identifier:
NCT02566902
Other Study ID Numbers:
- CR-15-047
First Posted:
Oct 2, 2015
Last Update Posted:
May 6, 2021
Last Verified:
Apr 1, 2021
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | T-piece Nebulizer | Breath-Enhanced Nebulizer |
|---|---|---|
| Arm/Group Description | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. T-Piece Nebulizer: Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. Breath-Enhanced Nebulizer: Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. |
| Period Title: Overall Study | ||
| STARTED | 60 | 58 |
| COMPLETED | 58 | 57 |
| NOT COMPLETED | 2 | 1 |
Baseline Characteristics
| Arm/Group Title | T-piece Nebulizer | Breath-Enhanced Nebulizer | Total |
|---|---|---|---|
| Arm/Group Description | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. T-Piece Nebulizer: Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. Breath-Enhanced Nebulizer: Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. | Total of all reporting groups |
| Overall Participants | 58 | 57 | 115 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
9.8
(2.6)
|
10.1
(3.0)
|
9.98
(2.82)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
21
36.2%
|
30
52.6%
|
51
44.3%
|
| Male |
37
63.8%
|
27
47.4%
|
64
55.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
30
51.7%
|
33
57.9%
|
63
54.8%
|
| Not Hispanic or Latino |
28
48.3%
|
24
42.1%
|
52
45.2%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
58
100%
|
57
100%
|
115
100%
|
| Baseline Asthma Severity (Count of Participants) | |||
| Mild Intermittent |
20
34.5%
|
27
47.4%
|
47
40.9%
|
| Mild Persistent |
11
19%
|
12
21.1%
|
23
20%
|
| Moderate Persistent |
20
34.5%
|
14
24.6%
|
34
29.6%
|
| Severe Persistent |
7
12.1%
|
4
7%
|
11
9.6%
|
| Weight (kg) (kilograms) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kilograms] |
39.5
(16.4)
|
41.1
(16.5)
|
40.7
(16.5)
|
| Duration of symptoms (days) (days) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [days] |
2
|
2
|
2
|
| Initial RR (bpm) (breaths/min) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [breaths/min] |
28.1
(9.4)
|
28.9
(7.6)
|
28.4
(8.5)
|
| Initial O2 (%saturation) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [%saturation] |
96.0
(2.1)
|
95.7
(2.6)
|
95.8
(2.4)
|
| Initial PAS score (units on a scale) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [units on a scale] |
4
|
4
|
4
|
| Initial PASS score (units on a scale) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [units on a scale] |
2
|
2
|
2
|
| Initial FEV1 (% predicted) (%predicted) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [%predicted] |
39.4
(13.4)
|
42
(14.8)
|
40.5
(14.4)
|
Outcome Measures
| Title | Change in FEV1 (% Predicted) |
|---|---|
| Description | Pre-treatment spirometry measurement assessed at the time of study enrollment. Post-treatment spirometry measurement assessed following the administration of one time 5mg nebulized albuterol sulfate treatment. Assessments taken at baseline (prior to albuterol therapy) and 10 min post-treatment. Change in FEV1 calculated as post-treatment FEV1 minus pre-treatment FEV1 |
| Time Frame | 10 minutes |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eight subjects unable to complete post-treatment spirometry (three in T-piece group, five in breath-enhanced group) |
| Arm/Group Title | T-piece Nebulizer | Breath-Enhanced Nebulizer |
|---|---|---|
| Arm/Group Description | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. T-Piece Nebulizer: Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. Breath-Enhanced Nebulizer: Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. |
| Measure Participants | 55 | 52 |
| Mean (95% Confidence Interval) [%predicted] |
13.8
|
9.1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | T-piece Nebulizer, Breath-Enhanced Nebulizer |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.04 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Change in PAS Score (Points on a Scale) |
|---|---|
| Description | Based on examination and auscultation of lungs prior to and immediately following albuterol administration. PAS score is on a scale of 0-10 which is a sum of five separate sub-scores each on a scale of 0-2. The five sub-scores are: Respiratory rate (6-12yr/>12yr): <=26/23 (0), 27-30/24-27 (1), >31/28 (2) Oxygenation: >95% (0), 90-95 (1), <90 (2) Auscultation: clear/end expiratory wheeze (0), expiratory wheeze (1), biphasic wheeze/diminished (2) Work of Breathing (accessory muscles): <= 1 (0), 2 (1), >=3 (2) Dyspnea: Full sentences (0), Partial sentences (1), Single words (2) Pre-treatment assessment at the time of study enrollment. Post-treatment assessment following the administration of one time 5mg nebulized albuterol sulfate treatment. Assessments taken at baseline (prior to albuterol therapy) and 10 min post-treatment. Change in PAS calculated as post-treatment PAS minus pre-treatment PAS. |
| Time Frame | 10 minutes |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | T-piece Nebulizer | Breath-Enhanced Nebulizer |
|---|---|---|
| Arm/Group Description | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. T-Piece Nebulizer: Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. Breath-Enhanced Nebulizer: Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. |
| Measure Participants | 58 | 57 |
| Median (Inter-Quartile Range) [score on a scale] |
-1
|
-2
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | T-piece Nebulizer, Breath-Enhanced Nebulizer |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.29 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Change in PASS Score (Points on a Scale) |
|---|---|
| Description | Determined by examination and auscultation of lungs to prior to and immediately following albuterol administration. PASS is a total score on a scale of 0-6 which is calculated as a sum of three sub-scores, each on a scale of 0-2. The sub-scores are: Wheezing: None or Mild (0), Moderate (1), Severe wheezing or absent wheezing due to poor air exchange (2) Work of breathing (accessory muscle use or retractions): None or mild (0), Moderate (1), Severe (2) Prolonged expiration: Normal or mildly prolonged (0), moderately prolonged (1), severely prolonged (2) Pre-treatment assessment at the time of study enrollment. Post-treatment assessment following the administration of one time 5mg nebulized albuterol sulfate treatment. Assessments taken at baseline (prior to albuterol therapy) and 10 min post-treatment. Change in PASS calculated as post-treatment PASS minus pre-treatment PASS. |
| Time Frame | 10 minutes |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | T-piece Nebulizer | Breath-Enhanced Nebulizer |
|---|---|---|
| Arm/Group Description | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. T-Piece Nebulizer: Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. Breath-Enhanced Nebulizer: Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. |
| Measure Participants | 58 | 57 |
| Median (Inter-Quartile Range) [score on a scale] |
-1
|
-1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | T-piece Nebulizer, Breath-Enhanced Nebulizer |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.97 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Percentage of Patients Requiring Inpatient Hospital Admission (% of Subjects) |
|---|---|
| Description | Admission rate to inpatient hospital will be assessed at the time of Emergency Department disposition which will be approximately 3 hours, but will be assessed up to 24 hours depending on duration of ED stay. |
| Time Frame | Up to 24 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | T-piece Nebulizer | Breath-Enhanced Nebulizer |
|---|---|---|
| Arm/Group Description | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. T-Piece Nebulizer: Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. Breath-Enhanced Nebulizer: Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. |
| Measure Participants | 58 | 57 |
| Count of Participants [Participants] |
11
19%
|
11
19.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | T-piece Nebulizer, Breath-Enhanced Nebulizer |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.96 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Emergency Department Length of Stay (Minutes) |
|---|---|
| Description | Total length of stay will be assessed at the time of Emergency Department disposition which will be approximately 3 hours, but will be assessed up to 24 hours depending on duration of ED stay. |
| Time Frame | Up to 24 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | T-piece Nebulizer | Breath-Enhanced Nebulizer |
|---|---|---|
| Arm/Group Description | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. T-Piece Nebulizer: Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. Breath-Enhanced Nebulizer: Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. |
| Measure Participants | 58 | 57 |
| Mean (95% Confidence Interval) [minutes] |
246.3
|
246.2
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | T-piece Nebulizer, Breath-Enhanced Nebulizer |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.99 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Percentage of Patients Experiencing Medication Side Effects (%) |
|---|---|
| Description | Subjects and parents/guardians will be asked whether subjects experienced nausea, vomiting, palpitations, headache, dizziness either during (assessed by non-blinded personnel) or following treatment (assessed by blinded personnel during post-treatment assessment). Subject and parent/guardian will also be asked if any "other" side effects were experienced. |
| Time Frame | 10 minutes |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | T-piece Nebulizer | Breath-Enhanced Nebulizer |
|---|---|---|
| Arm/Group Description | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. T-Piece Nebulizer: Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. Breath-Enhanced Nebulizer: Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. |
| Measure Participants | 58 | 57 |
| Count of Participants [Participants] |
5
8.6%
|
5
8.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | T-piece Nebulizer, Breath-Enhanced Nebulizer |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.00 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Total Quantity of Albuterol Given in the Emergency Department (mg) |
|---|---|
| Description | Cumulative dose of albuterol in mg will be assessed at the time of Emergency Department disposition which will be approximately 3 hours, but will be assessed up to 24 hours depending on duration of ED stay. |
| Time Frame | up to 24 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | T-piece Nebulizer | Breath-Enhanced Nebulizer |
|---|---|---|
| Arm/Group Description | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. T-Piece Nebulizer: Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. Breath-Enhanced Nebulizer: Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. |
| Measure Participants | 58 | 57 |
| Mean (95% Confidence Interval) [mg] |
18.2
|
18.7
|
| Title | Change Respiratory Rate (Breaths Per Minute) |
|---|---|
| Description | Respiratory rate will be measured by observation and auscultation over 30 seconds prior to and immediately following albuterol administration Pre-treatment assessment at the time of study enrollment. Post-treatment assessment following the administration of one time 5mg nebulized albuterol sulfate treatment. Assessments taken at baseline (prior to albuterol therapy) and 10 min post-treatment. Change in respiratory rate calculated as post-treatment respiratory rate minus pre-treatment respiratory rate. |
| Time Frame | 10 minutes |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | T-piece Nebulizer | Breath-Enhanced Nebulizer |
|---|---|---|
| Arm/Group Description | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. T-Piece Nebulizer: Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. Breath-Enhanced Nebulizer: Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. |
| Measure Participants | 58 | 57 |
| Mean (95% Confidence Interval) [breaths/min] |
-3.1
|
-3.2
|
| Title | Change in Heart Rate (Beats Per Minute) |
|---|---|
| Description | Blinded research personnel will assess subject's heart rate by auscultation and/or pulse palpation prior to and immediately following albuterol administration. Pre-treatment assessment at the time of study enrollment. Post-treatment assessment following the administration of one time 5mg nebulized albuterol sulfate treatment. Assessments taken at baseline (prior to albuterol therapy) and 10 min post-treatment. Change in heart rate calculated as post-treatment heart rate minus pre-treatment heart rate. |
| Time Frame | 10 minutes |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | T-piece Nebulizer | Breath-Enhanced Nebulizer |
|---|---|---|
| Arm/Group Description | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. T-Piece Nebulizer: Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. Breath-Enhanced Nebulizer: Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. |
| Measure Participants | 58 | 57 |
| Mean (95% Confidence Interval) [beats per minute] |
4.34
|
15.05
|
Adverse Events
| Time Frame | Duration of emergency department visit until the time of discharge or admission - up to 24 hours. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | T-piece Nebulizer | Breath-Enhanced Nebulizer | ||
| Arm/Group Description | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. T-Piece Nebulizer: Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. Breath-Enhanced Nebulizer: Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. | ||
All Cause Mortality |
||||
| T-piece Nebulizer | Breath-Enhanced Nebulizer | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/58 (0%) | 0/57 (0%) | ||
Serious Adverse Events |
||||
| T-piece Nebulizer | Breath-Enhanced Nebulizer | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/58 (0%) | 0/57 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| T-piece Nebulizer | Breath-Enhanced Nebulizer | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/58 (8.6%) | 5/57 (8.8%) | ||
| Cardiac disorders | ||||
| Palpitations | 1/58 (1.7%) | 1 | 1/57 (1.8%) | 1 |
| Gastrointestinal disorders | ||||
| Nausea | 1/58 (1.7%) | 1 | 1/57 (1.8%) | 1 |
| Vomiting | 0/58 (0%) | 0 | 1/57 (1.8%) | 1 |
| Nervous system disorders | ||||
| Shakiness, Jitteriness | 2/58 (3.4%) | 2 | 1/57 (1.8%) | 1 |
| Dizziness | 3/58 (5.2%) | 3 | 2/57 (3.5%) | 2 |
| Headache | 1/58 (1.7%) | 1 | 2/57 (3.5%) | 2 |
| Weakness | 1/58 (1.7%) | 1 | 0/57 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Mike Gardiner, MD |
|---|---|
| Organization | University of California - San Diego |
| Phone | 8589668036 |
| magardiner@ucsd.edu |
Responsible Party:
Seton Healthcare Family
ClinicalTrials.gov Identifier:
NCT02566902
Other Study ID Numbers:
- CR-15-047
First Posted:
Oct 2, 2015
Last Update Posted:
May 6, 2021
Last Verified:
Apr 1, 2021