NCT02975830

Brief Summary

Accurate understanding of tracheobronchial anatomy is important for application of various airway maneuvers in anesthesiology in children. Majority of pediatric anesthesia textbooks state that the anatomic orientation of the right main bronchus is at less acute angle to the vertical tracheal axis, although these angles tend to be similar in children younger than three years of ageThe visualization of the air column in tracheobronchial tree in a three-dimensional (3D) CT-based image is clear with the air column simulating the actual internal shape of the airway. We hypothesize that RBA and LBA are unequal as children like adults are prone to right mainstem intubation We have measured the right and left bronchial angle using the three dimensional CT based images of the air column in the tracheobronchial tree.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

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

March 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

9 months

First QC Date

November 23, 2016

Last Update Submit

January 1, 2017

Conditions

BronchusPediatric Airway

Outcome Measures

Primary Outcomes (1)

  • tracheobronchial angles

    6 months

Study Arms (4)

0-2 years

Children aged from birth to 24 months Three dimensional CT based images

Radiation: Three dimensional CT based images

2-4 Years

Children aged from 25-48 months Three dimensional CT based images

Radiation: Three dimensional CT based images

4-6 Years

Children aged from 49-72 Three dimensional CT based images

Radiation: Three dimensional CT based images

6-8 years

Children aged from 73-96 months Three dimensional CT based images

Radiation: Three dimensional CT based images

Interventions

Three dimensional CT based imagesRADIATION

Right bronchial angle, left bronchial angle

0-2 years2-4 Years4-6 Years6-8 years

Eligibility Criteria

AgeUp to 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

upto 8years of age

You may qualify if:

  • CT scans airways

You may not qualify if:

  • any disease that is anticipated to distort the normal shape of airways wee excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

November 23, 2016

First Posted

November 29, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 4, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share