NCT02771171

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

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
1 month until next milestone

First Submitted

Initial submission to the registry

May 11, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

4 months

First QC Date

May 11, 2016

Last Update Submit

August 29, 2016

Conditions

Keywords

Pediatric Airway, Three-dimensional Imaging, CT Scan

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Age groups

The cohort is divided into on the basis of age

Radiation: CT Scan

Interventions

CT ScanRADIATION

CT imaging

Age groups

Eligibility Criteria

Age1 Month - 96 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged 1 month to 8 years undergoing radiological evaluation (CT Imaging) unrelated to airways symptomatology

You may not qualify if:

  • 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.

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)

  • ECKENHOFF JE. Some anatomic considerations of the infant larynx influencing endotracheal anesthesia. Anesthesiology. 1951 Jul;12(4):401-10. doi: 10.1097/00000542-195107000-00001. No abstract available.

    PMID: 14847223BACKGROUND
  • 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.

  • 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.

Study Officials

  • Joseph D Tobias, MD

    Nationwide Children's Hospital, Columbus, Ohio

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 11, 2016

First Posted

May 12, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 30, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Locations