Measurement of the Distances of the Lower Airway in Pediatric Population

NCT ID: NCT04533334

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

299 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-09

Study Completion Date

2021-01-09

Brief Summary

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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

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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.

Conditions

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Airway Child Bronchus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pediatric

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

FOB measurement

Intervention Type PROCEDURE

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

Interventions

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FOB measurement

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Kadir Melih YILMAZ

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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PINAR Kendigelen, MD

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Locations

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Istanbul University-Cerrahpasa

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 19654121 (View on PubMed)

Other Identifiers

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26082020

Identifier Type: -

Identifier Source: org_study_id

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