Measurement of the Distances of the Lower Airway in Pediatric Population

Child Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04533334
• Other study ID #: 26082020
• Status: Completed
• Start date: January 9, 2019
• Est. completion date: January 9, 2021

Study information

• Verified date: May 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: January 9, 2021
• Est. primary completion date: January 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway
• Bronchus
• Child

Intervention

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

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper/Lower Airway Ratio	Ratio of the distance between labium oris to carina and carina to right upper lobe orifice	1 day
Secondary	Correlation between patient characteristics and distances measured by FOB	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