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Study was stopped after interim analysis and slow enrollment.
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The purpose of this study is to investigate whether heliox-powered albuterol nebulizer therapy will result in reduced inpatient length of stay in children hospitalized with acute asthma exacerbations.
We hypothesize that heliox-powered albuterol nebulizer therapy will result in reduced inpatient length of stay in children hospitalized with acute asthma exacerbations. Severity of asthma will be characterized using a modified Becker Clinical Asthma Score (CAS) based upon the acuity of physical signs for four clinical characteristics (respiratory rate, wheezing, I/E ratio, and accessory muscle use). Scoring will occur at the time of enrollment and every 4 hours thereafter until the patient meets hospital discharge criteria. All scoring using the CAS will be performed by an independent physician, nurse or respiratory therapist blinded to the subject treatment arm. All children will receive standard cardiopulmonary monitoring and treatment, consisting of supplemental oxygen delivered as needed by either nasal cannula or face mask to maintain oxygen saturation >90%, maintenance intravenous fluids, corticosteroid therapy and nebulized albuterol therapy. After written informed consent, eligible children will be randomized to one of two study groups using a sealed envelope technique:
Group 1 (Heliox-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 70:30 Heliox.
Group 2 (Oxygen-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 100% oxygen per usual standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Heliox-powered albuterol) | Experimental | Group 1 (Heliox-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 70:30 Heliox. |
|
| Group 2 (Oxygen-powered albuterol) | Active Comparator | Group 2 (Oxygen-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 100% oxygen per usual standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Helium-oxygen-driven albuterol nebulizer | Drug | Subjects will be treated with continuous albuterol nebs with Heliox |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | Time to discharge eligibility (hours) | Hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Derek S Wheeler, M.D. | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16338507 | Background | Rivera ML, Kim TY, Stewart GM, Minasyan L, Brown L. Albuterol nebulized in heliox in the initial ED treatment of pediatric asthma: a blinded, randomized controlled trial. Am J Emerg Med. 2006 Jan;24(1):38-42. doi: 10.1016/j.ajem.2005.06.007. | |
| 16263999 | Background | Kim IK, Phrampus E, Venkataraman S, Pitetti R, Saville A, Corcoran T, Gracely E, Funt N, Thompson A. Helium/oxygen-driven albuterol nebulization in the treatment of children with moderate to severe asthma exacerbations: a randomized, controlled trial. Pediatrics. 2005 Nov;116(5):1127-33. doi: 10.1542/peds.2004-2136. |
| Label | URL |
|---|---|
| Cincinnati Children's Hospital Medical Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Heliox Group | Patients randomized to the Heliox arm of the study |
| FG001 | Control Group | Subjects randomized to the control arm of the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Heliox Group | Patients randomized to the Heliox arm of the study |
| BG001 | Control Group | Subjects randomized to the control arm of the study |
| 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 | Length of Stay | Time to discharge eligibility (hours) | Posted | Mean | Standard Error | hours | Hospital discharge |
|
|
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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 | Heliox Group | Patients randomized to the Heliox arm of the study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Derek Wheeler | Cincinnati Children's Hospital Medical Center | 513-636-4239 | derek.wheeler@cchmc.org |
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| ID | Term |
|---|---|
| D013224 | Status Asthmaticus |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| Oxygen | Drug | Subjects will be treated with continuous albuterol nebs in oxygen |
|
| 16169793 | Background | Bandi V, Velamuri S, Sirgi C, Wendt J, Wendt R, Guntupalli K. Deposition pattern of heliox-driven bronchodilator aerosol in the airways of stable asthmatics. J Asthma. 2005 Sep;42(7):583-6. doi: 10.1080/02770900500216135. |
| 16141015 | Background | Lee DL, Hsu CW, Lee H, Chang HW, Huang YC. Beneficial effects of albuterol therapy driven by heliox versus by oxygen in severe asthma exacerbation. Acad Emerg Med. 2005 Sep;12(9):820-7. doi: 10.1197/j.aem.2005.04.020. |
| 12628892 | Background | Ho AM, Lee A, Karmakar MK, Dion PW, Chung DC, Contardi LH. Heliox vs air-oxygen mixtures for the treatment of patients with acute asthma: a systematic overview. Chest. 2003 Mar;123(3):882-90. doi: 10.1378/chest.123.3.882. |
| 11991886 | Background | Kress JP, Noth I, Gehlbach BK, Barman N, Pohlman AS, Miller A, Morgan S, Hall JB. The utility of albuterol nebulized with heliox during acute asthma exacerbations. Am J Respir Crit Care Med. 2002 May 1;165(9):1317-21. doi: 10.1164/rccm.9907035. |
| 12526234 | Background | Haynes JM, Sargent RJ, Sweeney EL. Use of heliox to avoid intubation in a child with acute severe asthma and hypercapnia. Am J Crit Care. 2003 Jan;12(1):28-30. No abstract available. |
| 11858916 | Background | Rose JS, Panacek EA, Miller P. Prospective randomized trial of heliox-driven continuous nebulizers in the treatment of asthma in the emergency department. J Emerg Med. 2002 Feb;22(2):133-7. doi: 10.1016/s0736-4679(01)00454-1. |
| 10919545 | Background | Dorfman TA, Shipley ER, Burton JH, Jones P, Mette SA. Inhaled heliox does not benefit ED patients with moderate to severe asthma. Am J Emerg Med. 2000 Jul;18(4):495-7. doi: 10.1053/ajem.2000.7365. No abstract available. |
| 10628607 | Background | Schaeffer EM, Pohlman A, Morgan S, Hall JB. Oxygenation in status asthmaticus improves during ventilation with helium-oxygen. Crit Care Med. 1999 Dec;27(12):2666-70. doi: 10.1097/00003246-199912000-00010. |
| 10453854 | Background | Kass JE, Terregino CA. The effect of heliox in acute severe asthma: a randomized controlled trial. Chest. 1999 Aug;116(2):296-300. doi: 10.1378/chest.116.2.296. |
| 9922408 | Background | Henderson SO, Acharya P, Kilaghbian T, Perez J, Korn CS, Chan LS. Use of heliox-driven nebulizer therapy in the treatment of acute asthma. Ann Emerg Med. 1999 Feb;33(2):141-6. doi: 10.1016/s0196-0644(99)70386-0. |
| 9042123 | Background | Kudukis TM, Manthous CA, Schmidt GA, Hall JB, Wylam ME. Inhaled helium-oxygen revisited: effect of inhaled helium-oxygen during the treatment of status asthmaticus in children. J Pediatr. 1997 Feb;130(2):217-24. doi: 10.1016/s0022-3476(97)70346-9. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Control Group | Subjects randomized to the control arm of the study | 0 | 20 | 0 | 20 |
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| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |