Clinical Trial: Functional Modeling of the Pediatric Airway

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Predictive Modeling for Treatment of Upper Airway Obstruction in Young Children

Brief Summary: The investigators hypothesize that a functional computational model that simulates the mechanical and aerodynamic behavior of the upper airway in children with Pierre Robin Sequence (PRS) and laryngeal lesions (e.g. subglottic stenosis or SGS) can be used as an effective diagnostic and treatment planning tool.

Detailed Summary:
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome: Change in Functional computational model outcome parameters [ Time Frame: years 1- 3 ]

Change in functional computational modeling parameters as compared to the change in percent of total time spent with oxygen saturation < 90% as noted on polysomnogram (physiologic measure) and change in airway measurements obtained via clinically indicated upper airway endoscopy (anatomic measure) pre and post-intervention(medical or surgical)


Original Primary Outcome: Same as current

Current Secondary Outcome: Validation of Computational model [ Time Frame: year 4 ]

Apply the computational model to infants and children being evaluated for Pierre Robin Sequence and Subglottic Stenosis, to determine the ability of the model to accurately predict the results of various potential interventions on anatomic and physiologic metrics.


Original Secondary Outcome: Same as current

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: July 30, 2012
Date Started: April 2011
Date Completion:
Last Updated: April 18, 2017
Last Verified: June 2016