NCT02925169

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
Last Updated

October 5, 2016

Status Verified

October 1, 2016

Enrollment Period

6 months

First QC Date

July 16, 2016

Last Update Submit

October 4, 2016

Conditions

Child

Keywords

Subglottis, cricoid, airway shape, CT imaging

Outcome Measures

Primary Outcomes (1)

  • Shape of airway in neonates and infants

    1 month

Interventions

CT ScanDEVICE

CT imaging

Eligibility Criteria

Age1 Day - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children less than 12 months of age

You may qualify if:

  • Neonates and infants.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Fahad Medical City

Riyadh, Riyadh Region, 11525, Saudi Arabia

Location

Related Publications (3)

  • 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.

    PMID: 26083203BACKGROUND

  • Sellars I, Keen EN. Laryngeal growth in infancy. J Laryngol Otol. 1990 Aug;104(8):622-5. doi: 10.1017/s0022215100113416.

    PMID: 2230557BACKGROUND

  • 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.

    PMID: 12502977BACKGROUND

MeSH Terms

Interventions

Tomography, X-Ray Computed

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Tariq Wani, MD

    King Fahad Medical City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, Pediatric Anesthesia

Study Record Dates

First Submitted

July 16, 2016

First Posted

October 5, 2016

Study Start

April 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 5, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)