Shape and Dimensions of the Upper Airway in Infants Using... | NCT02925169

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

NCT02925169

Sponsor

King Fahad Medical City

Status

Completed

Last Update Posted

Oct 5, 2016Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Child

Interventions

CT Scan

Countries

Saudi Arabia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Oct 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Jul 16, 2016

First Submission Date that Met QC Criteria

Oct 4, 2016

First Posted Date

Oct 5, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2016

Last Update Posted Date

Oct 5, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tariq Wani, Consultant, Pediatric Anesthesia, King Fahad Medical CityPrincipal Investigator

Lead Sponsor

King Fahad Medical CityOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Name	Type	Description	Arm Group Labels	Other Names
CT Scan	Device	CT imaging

Measure	Description	Time Frame
Shape of airway in neonates and infants		1 month

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

12 Months

Standard Ages

Child

Study Population

Children less than 12 months of age

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tariq Wani, MD	King Fahad Medical City	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King Fahad Medical City		Riyadh	Riyadh Region	11525	Saudi Arabia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26083203	Background	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.
2230557	Background	Sellars I, Keen EN. Laryngeal growth in infancy. J Laryngol Otol. 1990 Aug;104(8):622-5. doi: 10.1017/s0022215100113416.

ID	Term
D007090	Image Interpretation, Computer-Assisted
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis