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Completed

NCT Number: NCT04533334

Measurement of the Distances of the Lower Airway in Pediatric Population

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).

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Key information

Conditions

Airway Bronchus Child

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University-Cerrahpasa

Istanbul, 34098, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FOB measurement

Procedure

A FOB will be inserted after anesthesia induction and the distances will be measured by direct observation via the bronchoscope.

Primary outcomes

  1. Upper/Lower Airway Ratio

    Time frame: 1 day

    Ratio of the distance between labium oris to carina and carina to right upper lobe orifice

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 31, 2020
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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