Measurement of the Distances of the Lower Airway in Pediatric Population

Completed

• Conditions: Child; Bronchus; Airway
• Interventions: Procedure: FOB measurement

• Registration Number: NCT04533334
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

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).

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 Timeline

• Study Start: 2019-01-09
• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-31
• Primary Completion: 2021-01-09
• Study Completion: 2021-01-09
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-01
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric	FOB measurement	FOB measurement of the distance between carina and right upper lobe bronchus and carina and labium oris in pediatric population

Primary Outcome Measures

Name	Time	Method
Upper/Lower Airway Ratio	1 day	Ratio of the distance between labium oris to carina and carina to right upper lobe orifice

Secondary Outcome Measures

Name	Time	Method
Correlation between patient characteristics and distances measured by FOB	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

Trial Locations

Locations (1)

Istanbul University-Cerrahpasa; 🇹🇷 Istanbul, Turkey