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Assessing Response to Albuterol in Bronchiolitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01238445
First Posted: November 10, 2010
Last Update Posted: February 2, 2017
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.
Information provided by (Responsible Party):
Christopher Carroll, MD, Connecticut Children's Medical Center
November 8, 2010
November 10, 2010
February 2, 2017
November 2010
November 2016   (Final data collection date for primary outcome measure)
Our primary outcome is the response to albuterol. [ Time Frame: 20 minutes following an albuterol treatment ]
Same as current
Complete list of historical versions of study NCT01238445 on ClinicalTrials.gov Archive Site
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Assessing Response to Albuterol in Bronchiolitis
Assessing Response to Albuterol in Bronchiolitis
Bronchiolitis is a significant cause of morbidity and hospitalizations in children, accounting for more than 125,000 hospitalized children per year in the United States. Although treatment is largely supportive, bronchodilator medications such as albuterol are frequently used due to increased pulmonary resistance in this population.2-4 However, despite four decades of clinical trials, the efficacy of albuterol in the treatment of bronchiolitis has yet to be proven. This inconsistency is due in part to the lack of sufficiently sensitive methods for the evaluation of lung function and thus the response to albuterol in infants. Because of the difficulties in evaluating the response to therapy, healthcare providers are forced to rely on their physical examination skills or a clinical scoring system, both of which are highly subjective in this population. The investigators propose to conduct a prospective observational study of healthcare providers to determine the accuracy of clinical assessment as compared to that of pulmonary mechanics in a population of children intubated and mechanically ventilated for bronchiolitis.
We propose to conduct a prospective observational study of healthcare providers to determine the accuracy of clinical assessment as compared to the assessment of pulmonary mechanics in a population of children intubated and mechanically ventilated for bronchiolitis. Before and at 20 minutes following a routinely scheduled albuterol treatment, measurements of pulmonary mechanics obtained as part of the child's clinical care will be compared to a healthcare provider's simultaneous clinical assessment. Three healthcare providers (a nurse, physician, and respiratory therapist) will assess the child during these time periods. Data regarding their observations will be recorded using a data collection tool (attached). Healthcare providers will be blinded to each other's assessments and to the measurements of pulmonary mechanics. Using sensitivity and specificity analysis, the healthcare provider's assessment of response will be compared to the standard assessment of response according to the measurements of pulmonary mechanics. A precision of the estimate of sensitivity and specificity will be calculated. Clinical characteristics of the child will be recorded. Each child may be assessed on up to three occasions if that child receives greater than 1 dose of albuterol. However, no more than 3 providers will assess the child at one time.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample
Children hospitalized in the intensive care unit with bronchiolitis
Bronchiolitis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
November 2016
November 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hospitalization with a primary admission diagnosis of bronchiolitis
  • Age between birth and 2 years
  • Intubated with < 1 cm H2O leak around endotracheal tube
  • Receiving inhaled albuterol therapy

Exclusion Criteria:

- Not meeting inclusion criteria

Sexes Eligible for Study: All
up to 2 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01238445
10-095
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Christopher Carroll, MD, Connecticut Children's Medical Center
Connecticut Children's Medical Center
Not Provided
Principal Investigator: Christopher L Carroll, MD, MS Connecticut Children's Medical Center
Connecticut Children's Medical Center
January 2017
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