Volumetric Three-dimensional Analysis of the Pediatric Upper Airway Shape Using Computed Tomography Imaging.

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.

Study Overview

• Status: Completed
• Conditions: Airway Management
• Intervention / Treatment: Radiation: CT Scan

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11525
    • King Fahad Medical City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children aged 1 month to 8 years undergoing radiological evaluation (CT Imaging) unrelated to airways symptomatology

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Age groups; The cohort is divided into on the basis of age	Radiation: CT Scan; CT imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shape of the pediatric Airway	The purpose of this study was to determine the shape of pediatric airway from subglottis to the trachea using 3D dimensional CT air column images. The shape of the airway was calculated on the basis of the volumes of airway column at the level of subglottis, cricoid and trachea	12 months

Collaborators and Investigators

• Sponsor: King Fahad Medical City
• Investigators: Study Director: Joseph D Tobias, MD, Nationwide Children's Hospital, Columbus, Ohio

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: May 11, 2016
• First Submitted That Met QC Criteria: May 11, 2016
• First Posted (Estimate): May 12, 2016

Study Record Updates

• Last Update Posted (Estimate): August 30, 2016
• Last Update Submitted That Met QC Criteria: August 29, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Pediatric Airway, Three-dimensional Imaging, CT Scan
• Other Study ID Numbers: IRB (University Hospital in Lund)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No