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

Airway Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02771171
• Other study ID #: IRB
• Status: Completed
• Phase: N/A
• First received: May 11, 2016
• Last updated: August 29, 2016
• Start date: April 2016
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: King Fahad Medical City
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 96 Months

Eligibility

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.

Related Conditions & MeSH terms

• Airway Management

Intervention

Radiation:
• CT Scan
CT imaging

Locations

Country	Name	City	State
Saudi Arabia	King Fahad Medical City	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Fahad Medical City

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (3)

ECKENHOFF JE. Some anatomic considerations of the infant larynx influencing endotracheal anesthesia. Anesthesiology. 1951 Jul;12(4):401-10. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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