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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02771171
Other study ID # IRB
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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