Functional Modeling of the Pediatric Airway

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Completed

CT.gov ID

NCT01690078

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Location

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Subglottic Stenosis (SGS) Pierre Robin Sequence (PRS) Micrognathia Normal Controls From CT Scans of the Upper Airway

Study Design

Study Type:

Observational

Actual Enrollment :

39 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Predictive Modeling for Treatment of Upper Airway Obstruction in Young Children

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Cross sectional Cross sectional study where subjects with PRS, micrognathia, or SGS will have a single study visit that will be scheduled within 14 days of a clinically indicated upper airway endoscopy. CT scans of the neck or maxillofacial CT will be obtained in all subjects. During upper airway endoscopy, airway measurements will be conducted. Cohort may include subjects who have previously undergone medical or surgical intervention for their airway obstruction, or who are currently undergoing multidisciplinary team management. The following data will be collected: clinical parameters, Obstructive Sleep Apnea (OSA)OSA-18 (quality of life) questionnaire, and lung function tests (subjects > 4 years of age). Clinically indicated swallowing studies and voice evaluations will be collected.
Longitudinal The prospective, longitudinal cohort arm of the study is designed to describe the effects of treatment on clinical and computational model endpoints. This is performed in a subset of subjects with PRS, micrognathia, or SGS who are scheduled for clinically indicated upper airway endoscopy and who are scheduled to complete a definitive treatment course which necessitates multiple endoscopic evaluations and follow-up imaging. Subjects will have an entry visit comparable to the cross-sectional entry visit. Longitudinal subjects will have up to 3 additional study visits over a 12 to 15-month period.
Normal Control Data Normal de-identified control data is retrospectively collected from clinically indicated CT scans of the neck and maxillofacial CT scans in children less than 18 years of age.

Outcome Measures

Primary Outcome Measures

Change in Functional computational model outcome parameters [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)

Secondary Outcome Measures

Validation of Computational model [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Micrognathia, Suspected or Diagnosis of PRS, defined (Gorlin) as:

micrognathia (mandibular hypoplasia), cleft palate and airway obstruction, and/or

Diagnosis of SGS defined (Bluestone) as:

subglottic airway diameter of 4 mm or less in a term neonate;
subglottic airway diameter of 3.5 mm or less in a premature neonate;
inability to pass an endotracheal tube of expected size for age

Informed consent by parent or legal guardian
Age < 18 years at enrollment
Scheduled for clinically indicated endoscopic upper airway evaluation
Ability to comply with study visits and study procedures as judged by the site investigator

Inclusion criterion also included for Specific Aim 2 (Longitudinal):

Subjects must be scheduled for an operative procedure to correct or bypass upper airway obstruction (i.e. mandibular distraction, endoscopic airway surgery, laryngotracheoplasty, cricotracheal resection, or tracheostomy) OR recently (within past 4 weeks) diagnosed as having an anomaly not currently requiring surgical management.

Exclusion Criteria:

Acute, intercurrent respiratory infection, defined as an increase from baseline in cough, wheezing, or respiratory rate with onset in the preceding week.
Physical findings at screening that would compromise the safety of the participant or the quality of the study (i.e. fever, increased respiratory rate above baseline, significant acute emesis, or alteration in baseline neurologic status).
For research CT scans any sedation risk, such as Bronchopulmonary Dysplasia (BPD) with upper airway obstruction, residual oxygen requirement, and an unsecured airway.

Control data will be collected from clinically indicated neck or maxillofacial CT imaging data that include the entire airway with no noted airway obstructions or airway abnormalities.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Carolina Children's Hospital	Chapel Hill	North Carolina	United States	27514

Sponsors and Collaborators

University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator: Stephanie D Davis, MD, Indiana University School of Medicine
Principal Investigator: Carlton Zdanski, MD, University of North Carolina, Chapel Hill
Principal Investigator: Richard Superfine, PhD, University of North Carolina, Chapel Hill