Clinical trial NCT04533334: Measurement of the Distances of the Lower Airway in Pediatric Population
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway
Child
Bronchus
Keywords: anesthesia
fiberoptic bronchoscopy
lower airway anatomy
child
right upper lobe bronchus
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 299
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing general anesthesia via an endotracheal tube will be eligible for recruitment.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Upper/Lower Airway Ratio
timeFrame: 1 day
Secondary outcomes:
measure: Correlation between patient characteristics and distances measured by FOB
timeFrame: 1 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: PINAR Kendigelen, MD
role: STUDY_DIRECTOR
References:
citation: 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.