We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00410150
Recruitment Status : Terminated (Study was stopped after interim analysis and slow enrollment.)
First Posted : December 12, 2006
Results First Posted : October 13, 2010
Last Update Posted : November 8, 2010
Sponsor:
Information provided by:
Children's Hospital Medical Center, Cincinnati

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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
Total Total of all reporting groups

Baseline Measures
   Heliox Group   Control Group   Total 
Overall Participants Analyzed 
[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 ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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:


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
First Submitted: December 11, 2006
First Posted: December 12, 2006
Results First Submitted: September 15, 2010
Results First Posted: October 13, 2010
Last Update Posted: November 8, 2010