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.

Study Overview

• Status: Completed
• Conditions: Bronchiolitis

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Connecticut Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children hospitalized in the intensive care unit with bronchiolitis

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Our primary outcome is the response to albuterol.	20 minutes following an albuterol treatment

Collaborators and Investigators

• Sponsor: Connecticut Children's Medical Center
• Investigators: Principal Investigator: Christopher L Carroll, MD, MS, Connecticut Children's Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: November 8, 2010
• First Submitted That Met QC Criteria: November 9, 2010
• First Posted (Estimate): November 10, 2010

Study Record Updates

• Last Update Posted (Estimate): February 2, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Pediatric
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: 10-095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No