Measurement of the Distances of the Lower Airway in Pediatric Population
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
1 other identifier
observational
299
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 9, 2019
CompletedFirst Submitted
Initial submission to the registry
August 26, 2020
CompletedFirst Posted
Study publicly available on registry
August 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2021
CompletedMay 3, 2023
May 1, 2023
2 years
August 26, 2020
May 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Upper/Lower Airway Ratio
Ratio of the distance between labium oris to carina and carina to right upper lobe orifice
1 day
Secondary Outcomes (1)
Correlation between patient characteristics and distances measured by FOB
1 day
Study Arms (1)
Pediatric
FOB measurement of the distance between carina and right upper lobe bronchus and carina and labium oris in pediatric population
Interventions
A FOB will be inserted after anesthesia induction and the distances will be measured by direct observation via the bronchoscope.
Eligibility Criteria
All patients undergoing general anesthesia via an endotracheal tube will be eligible for recruitment.
You may qualify if:
- All patients undergoing general anesthesia via an endotracheal tube
- ASA I-III
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul University-Cerrahpasa
Istanbul, 34098, Turkey (Türkiye)
Related Publications (1)
Rudraraju P, Eisen LA. Confirmation of endotracheal tube position: a narrative review. J Intensive Care Med. 2009 Sep-Oct;24(5):283-92. doi: 10.1177/0885066609340501. Epub 2009 Aug 3.
PMID: 19654121BACKGROUND
Study Officials
- STUDY DIRECTOR
PINAR Kendigelen, MD
Istanbul University - Cerrahpasa
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 26, 2020
First Posted
August 31, 2020
Study Start
January 9, 2019
Primary Completion
January 9, 2021
Study Completion
January 9, 2021
Last Updated
May 3, 2023
Record last verified: 2023-05