Clinical trial NCT02771171: Volumetric Three-dimensional Analysis of the Pediatric Upper Airway Shape Using Computed Tomography Imaging.
Official title: Volumetric Three-dimensional Analysis of the Pediatric Upper Airway Shape Using Computed Tomography Imaging.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Management
Keywords: Pediatric Airway, Three-dimensional Imaging, CT Scan
Lead sponsor: King Fahad Medical City
Sponsor class: OTHER_GOV
First posted: 2016-05-12
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 96
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 1 month to 8 years undergoing radiological evaluation (CT Imaging) unrelated to airways symptomatology

Brief summary: CT and MRI based measurements of the pediatric airway has changed the age-old cone shape concept of the pediatric airway and define airway shape as elliptical structure. The cone shape was based on the cadaveric measurements done by Bayeux in 1897 and described later by Eckenhoff in 1951.

The present study is based on three-dimensional CT images of the airway column replicating the cylinders used by Bayeux for his cadaveric measurements. The purpose of this study was to determine the cone shape of the pediatric airway.

Detailed description: This is a retrospective review of three-dimensional CT air column images of 60 children aged 1 month to 8 years undergoing radiological evaluation unrelated to airways symptomatology. The CT scans will be evaluated in children either sleeping naturally or sedated throughout the study period. Volumetric analysis of the air-column was done at the level of cricoid, subglottis and trachea

Exclusion Criteria:

Patients with a tracheostomy or endotracheal tube in place, tracheo-esophageal fistula, pulmonary collapse or atelectasis, mediastinal mass, diaphragmatic hernia, extrapulmonary and intrathoracic mass, preterm infants, and patients with genetic syndromes and primary lung diseases.

Patients with poor image quality were also excluded from the study.

Eligibility criteria: Inclusion Criteria: Children aged 1 month to 96 months

Exclusion Criteria:

Patients with a tracheostomy or endotracheal tube in place, tracheo-esophageal fistula, pulmonary collapse or atelectasis, mediastinal mass, diaphragmatic hernia, extrapulmonary and intrathoracic mass, preterm infants, and patients with genetic syndromes and primary lung diseases Patients with poor image quality were also excluded from the study.

Primary outcomes:
measure: Shape of the pediatric Airway
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City
Study officials:
affiliation: Nationwide Children's Hospital, Columbus, Ohio
name: Joseph D Tobias, MD
role: STUDY_DIRECTOR
References:
citation: ECKENHOFF JE. Some anatomic considerations of the infant larynx influencing endotracheal anesthesia. Anesthesiology. 1951 Jul;12(4):401-10. doi: 10.1097/00000542-195107000-00001. No abstract available.
citation: Wani TM, Bissonnette B, Rafiq Malik M, Hayes D Jr, Ramesh AS, Al Sohaibani M, Tobias JD. Age-based analysis of pediatric upper airway dimensions using computed tomography imaging. Pediatr Pulmonol. 2016 Mar;51(3):267-71. doi: 10.1002/ppul.23232. Epub 2015 Jun 17.
citation: Litman RS, Weissend EE, Shibata D, Westesson PL. Developmental changes of laryngeal dimensions in unparalyzed, sedated children. Anesthesiology. 2003 Jan;98(1):41-5. doi: 10.1097/00000542-200301000-00010.