Heliox-Powered Albuterol Therapy in the Treatment of Children Admitted With Acute Asthma Exacerbation
NCT ID: NCT00410150
Last Updated: 2010-11-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
42 participants
INTERVENTIONAL
2006-04-30
2007-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1 (Heliox-powered albuterol)
Group 1 (Heliox-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 70:30 Heliox.
Helium-oxygen-driven albuterol nebulizer
Subjects will be treated with continuous albuterol nebs with Heliox
Group 2 (Oxygen-powered albuterol)
Group 2 (Oxygen-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 100% oxygen per usual standard of care.
Oxygen
Subjects will be treated with continuous albuterol nebs in oxygen
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Helium-oxygen-driven albuterol nebulizer
Subjects will be treated with continuous albuterol nebs with Heliox
Oxygen
Subjects will be treated with continuous albuterol nebs in oxygen
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Previous history of asthma;
* Hospital admission for acute asthma exacerbation;
* Clinical asthma score greater than or equal to 3
Exclusion Criteria
* Known allergy or hypersensitivity to ß-agonists;
* Require mechanical ventilation (invasive or non-invasive);
* Require FiO2 \>0.4;
* Failure to obtain informed consent;
* Enrollment in another investigational drug or asthma protocol;
* Incipient respiratory failure including but limited to respiratory acidosis(pCO2\>60 torr), altered mental status and/or excessive work of breathing.
24 Months
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Cincinnati Children's Hospital Medical Center
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Derek S Wheeler, M.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Cincinnati Children's Hospital Medical Center
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
05-11-34-74-067
Identifier Type: -
Identifier Source: org_study_id