Heliox-Powered Albuterol Therapy in the Treatment of Children Admitted With Acute Asthma Exacerbation

This study has been terminated.

( Study was stopped after interim analysis and slow enrollment. )

Study NCT00410150 Information provided by Children's Hospital Medical Center, Cincinnati

First Received on December 11, 2006. Last Updated on October 22, 2010 History of Changes

Results First Received: September 15, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Outcomes Assessor); Primary Purpose: Treatment
Condition:	Status Asthmaticus
Interventions:	Drug: Helium-oxygen-driven albuterol nebulizer Drug: Oxygen

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Heliox Group	Patients randomized to the Heliox arm of the study
Control Group	Subjects randomized to the control arm of the study

Participant Flow: Overall Study

	Heliox Group	Control Group
STARTED	22	20
COMPLETED	20 ^[1]	17 ^[2]
NOT COMPLETED	2	3

[1]	2 study withdrawals (analyzed by intention-to-treat)
[2]	3 study withdrawals (analyzed by intention-to-treat0

Baseline Characteristics

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Reporting Groups

	Description
Heliox Group	Patients randomized to the Heliox arm of the study
Control Group	Subjects randomized to the control arm of the study

Baseline Measures

	Heliox Group	Control Group	Total
Number of Participants [units: participants]	22	20	42
Age [units: participants]
<=18 years	22	20	42
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	7.3 ± 0.8	8.2 ± 0.9	7.8 ± 0.8
Gender [units: participants]
Female	9	6	15
Male	13	14	27
Region of Enrollment [units: participants]
United States	22	20	42

Outcome Measures

1. Primary:

Length of Stay [ Time Frame: Hospital discharge ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Dr. Derek Wheeler
Organization: Cincinnati Children's Hospital Medical Center
phone: 513-636-4239
e-mail: derek.wheeler@cchmc.org

Publications:

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.

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.

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.

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.

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. Review.

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.

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.

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. 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.

Kass JE, Terregino CA. The effect of heliox in acute severe asthma: a randomized controlled trial. Chest. 1999 Aug;116(2):296-300.

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.

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.

Responsible Party:	Derek Wheeler, Cincinnati Children's Hospital Medical Center
ClinicalTrials.gov Identifier:	NCT00410150 History of Changes
Other Study ID Numbers:	05-11-34-74-067
Study First Received:	December 11, 2006
Results First Received:	September 15, 2010
Last Updated:	October 22, 2010
Health Authority:	United States: Food and Drug Administration