Functional Modeling of the Pediatric Airway

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

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

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT01690078
10-1634
R01HL105241 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

39 patients

Sex

All

Ages

Under 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. 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
  2. Informed consent by parent or legal guardian

  3. Age < 18 years at enrollment

  4. Scheduled for clinically indicated endoscopic upper airway evaluation

  5. 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

  1. Acute, intercurrent respiratory infection, defined as an increase from baseline in cough, wheezing, or respiratory rate with onset in the preceding week.
  2. 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).
  3. 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.

Trial design

39 participants in 3 patient groups

Cross sectional
Description:
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
Description:
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
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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