- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03030781
Relationship of Cricoid With the Right and Left Bronchial Diameters in the Pediatric Population Using Three-dimensional Imaging.
Study Overview
Status
Conditions
Detailed Description
Understanding the relationship between cricoid and mainstem bronchi can provide to be a useful adjunct for lung isolation in children. The relationship between cricoid dimensions and the dimensions of main-stem bronchi (right and left) have been studied using 2 dimensional CT images and video-bronchoscopic images. The present study defines the volume-based relationship between the right main-stem bronchus (RMSB), left main-stem bronchus (LMSB) and the cricoid ring based on 3 dimensional CT derived images.
Methods: The three dimensional CT images of 35 children, younger than 8 years, undergoing radiological evaluation unrelated to airway symptomatology were examined. The children were evaluated during spontaneous ventilation without airway devices either during natural sleep or with sedation. The 3-dimensional images of the airway column were evaluated at the level of cricoid, right mainstem bronchus and left main-stem bronchus, volumes were calculated and comparisons made between these levels. Univariate and multivariate regression analysis was used to determine whether one or more of the variables (age, gender, height, weight and cricoid) had a predictable relationship to the RMSB and the LMSB diameter.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children 1 month to 8 years of age
Exclusion Criteria:
- Patients with tracheostomy Tracheoesophageal fistula Presence of mediastinal mass Diaphragmatic hernia Preterm infants
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
comparison between cricoid and mainstem borncchi
Time Frame: 1 month to 8 years
|
1 month to 8 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H-01-R-012, 17-010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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