Measurement of the Distances of the Lower Airway in Pediatric Population

May 1, 2023 updated by: Kadir Melih YILMAZ, Istanbul University - Cerrahpasa (IUC)

Measurement of the Distance Between the Orifice of the Right Upper Lobe and Carinae and Labium Oris With Fiberoptic Bronchoscopy in Pediatric Population in Turkey

Pediatric patients are exposed to increased risk during general anesthesia. A myriad of problems can be encountered in the pediatric population by misplaced endotracheal tubes. Especially, during one-lung ventilation (OLV) a right-sided or left-sided tube is inserted to facilitate the surgery. However, inadvertent tube use, caused by misinterpretation of the distances of the trachea and the main bronchi, may cause unintended hypoxemia, postoperative atelectasis and even mortality.

In this study, investigators will measure the distance between distal margin of right lung upper lobe orifice-carina and carina-lip with the help of fiberoptic bronchoscopy (FOB).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In ASA-PS I-II-III children between 1-18 years of age who are orotracheally intubated for any reason, the fiber optic bronchoscope will be advanced in the tube and first the carina distance and then the carina to right upper bronchus distance will be measured.

Age, weight, height, body mass index (BMI), weight percentile, height percentile, comorbidities, ASA score, tube size, lip margin distance, right upper bronchus to carina distance and right upper lobe to carina distance/ Carina to-lip margin ratio will be recorded.

Study Type

Observational

Enrollment (Actual)

299

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey, 34098
        • Istanbul University-Cerrahpasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing general anesthesia via an endotracheal tube will be eligible for recruitment.

Description

Inclusion Criteria:

  • All patients undergoing general anesthesia via an endotracheal tube
  • ASA I-III

Exclusion Criteria:

  • Patients that do not meet age criteria
  • Uncontrolled asthma or hyper reactive airway
  • hypoxemia, previous thoracic surgery
  • ASA > III
  • Unstable hemodynamics
  • Patients with tracheal or oral malignancies
  • Patients with face trauma
  • Informed consent not given
  • using a tube with a number too small for the fiberoptic bronchoscope to pass through

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pediatric
FOB measurement of the distance between carina and right upper lobe bronchus and carina and labium oris in pediatric population
Procedure: FOB measurement
A FOB will be inserted after anesthesia induction and the distances will be measured by direct observation via the bronchoscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper/Lower Airway Ratio
Time Frame: 1 day
Ratio of the distance between labium oris to carina and carina to right upper lobe orifice
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between patient characteristics and distances measured by FOB
Time Frame: 1 day
Correlation between age, body mass index, gender, percentiles and the distance between labium oris to carina and carina to right upper lobe orifice
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Collaborators

Ayse Cigdem Tutuncu
Kaya, Guner, M.D.
Pinar Kendigelen

Investigators

  • Study Director: PINAR Kendigelen, MD, Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2019

Primary Completion (Actual)

January 9, 2021

Study Completion (Actual)

January 9, 2021

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

August 31, 2020

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 1, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26082020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data available on reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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