Functional Modeling of the Pediatric Airway

NCT01690078 | Completed DMC

• 2 other identifiers: 10-1634R01HL105241
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Subglottic Stenosis (SGS); Pierre Robin Sequence (PRS); Micrognathia; Normal Controls From CT Scans of the Upper Airway

Keywords

Airway modeling; Pierre Robin Sequence or PRS; Micrognathia; Subglottic Stenosis or SGS

Outcome Measures

Primary Outcomes (1)

• Change in Functional computational model outcome parameters

  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)

  years 1- 3

Secondary Outcomes (1)

• Validation of Computational model

  year 4

Study Arms (3)

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.

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children \< 18 years of age with a diagnosis of either Pierre Robin Sequence, Micrognathia or Subglottic Stenosis. Clinically indicated control data will be collected from CT scans of neck and maxillofacial CT scans performed on children \< 18 years of age

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

North Carolina Children's Hospital

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (8)

• Calloway HE, Kimbell JS, Davis SD, Retsch-Bogart GZ, Pitkin EA, Abode K, Superfine R, Zdanski CJ. Comparison of endoscopic versus 3D CT derived airway measurements. Laryngoscope. 2013 Sep;123(9):2136-41. doi: 10.1002/lary.23836.

  PMID: 24167819 BACKGROUND

• Mitran S. Continuum-kinetic-microscopic model of lung clearance due to core-annular fluid entrainment. J Comput Phys. 2013 Jul 1;244:193-211. doi: 10.1016/j.jcp.2013.01.037.

  PMID: 23729842 BACKGROUND

• Mitran (2012c), Predictive Modeling of Upper Airway Flow in Young Children, Proceedings, 34th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC'12), San Diego, CA, (accepted).

  BACKGROUND

• Mitran, S. (2012b), "Lattice Fokker-Planck Method Based on Wasserstein Gradient Flows", Phys. Rev.E., (under review).

  BACKGROUND

• Alabi OS, Wu X, Harter JM, Phadke M, Pinto L, Petersen H, Bass S, Keifer M, Zhong S, Healey C, Taylor RM 2nd. Comparative Visualization of Ensembles Using Ensemble Surface Slicing. Proc SPIE Int Soc Opt Eng. 2012 Jan 22;8294:82940U. doi: 10.1117/12.908288.

  PMID: 23560167 BACKGROUND

• Yi Hong, Yundi Shi, Martin Styner, Mar Sanchez, and Marc Niethammer. Simple Geodesic Regression for Image Time-Series. Accepted to the 5th Workshop on Biomedical Image Registration. 2012.

  BACKGROUND

• Hong Y, Joshi S, Sanchez M, Styner M, Niethammer M. Metamorphic geodesic regression. Med Image Comput Comput Assist Interv. 2012;15(Pt 3):197-205. doi: 10.1007/978-3-642-33454-2_25.

  PMID: 23286131 BACKGROUND

• Zdanski, C., Kimbell, J.S., Superfine, R.S., and Davis, S. (2012). Computational Fluid Dynamics Modeling of the Pediatric Airway Utilizing Computed Tomography in Children with Pierre Robin Sequence. Poster presentation, European Society of Pediatric Otolaryngology, Amsterdam, The Netherlands, May 20-23, 2012.

  BACKGROUND

MeSH Terms

Conditions

Pierre Robin Syndrome; Micrognathism; Prieto X-linked mental retardation syndrome

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: September 21, 2012
• Study Start: April 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 20, 2017

Record last verified: 2016-06

Locations

US (1)