Shape and Dimensions of the Upper Airway in Infants Using Computed Tomography Imaging

Child Clinical Trial

Official title:

Shape and Dimensions of the Upper Airway in Infants Using Computed Tomography Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02925169
• Other study ID #: H-01-R-012
• Status: Completed
• Phase: N/A
• First received: July 16, 2016
• Last updated: October 4, 2016
• Start date: April 2016
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: King Fahad Medical City
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Cricoid is considered the narrowest part with the shape of airway defined as elliptical with the subglottis as the narrowest region.

This study using imaging modality (2D CT images) is done to determine any differences in airway shape between infants and children, and to evaluate the dimensional transition between the subglottic area and the cricoid ring.

Description:

Using imaging modalities (CT, MRI), the funnel-shape of the airway in children has been questioned and subglottis rather than cricoid is considered the narrowest part with the shape of airway defined as elliptical with the subglottis as the narrowest region.

This is the first study using imaging modality (2D CT images) to determine the airway shape and dimensions in neonates and infants. The purpose of this investigation was to determine any differences in airway shape between infants and children, and to evaluate the dimensional transition between the subglottic area and the cricoid ring.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

Inclusion Criteria:

• Neonates and infants.

Exclusion Criteria:

Patients with tracheostomy, tracheo-esophageal fistulas lung collapse mediastinal masses diaphragmatic hernias chest masses intubated patients patients, preterm infants syndromic patients patients with primary lung diseases

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Child

Intervention

Device:
• 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)

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

Sellars I, Keen EN. Laryngeal growth in infancy. J Laryngol Otol. 1990 Aug;104(8):622-5. — 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 Jun 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shape of airway in neonates and infants		1 month	No