Assessing Response to Albuterol in Bronchiolitis

Bronchiolitis Clinical Trial

Official title:

Assessing Response to Albuterol in Bronchiolitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01238445
• Other study ID #: 10-095
• Status: Completed
• Phase: N/A
• First received: November 8, 2010
• Last updated: January 31, 2017
• Start date: November 2010
• Est. completion date: November 2016

Study information

• Verified date: January 2017
• Source: Connecticut Children's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis

Locations

Country	Name	City	State
United States	Connecticut Children's Medical Center	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Connecticut Children's Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Our primary outcome is the response to albuterol.		20 minutes following an albuterol treatment