3D Airway Model for Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
To determine the correct size of endotracheal tubes (ETT) for endotracheal intubation of pediatric patients is no menial task. Although new methods have been investigated to determine ETT size, and the three-dimensional (3D) printing technology has been successful in the field of surgery, there are not many studies in the field of anesthesia. The purpose of this study is to evaluate the accuracy of a 3D airway model for prediction of the correct ETT size, and compare the results with a conventional age-based formula in pediatric patients. : Thirty five pediatric patients under 6 years of age who were scheduled for congenital heart surgery. In the pre-anaesthetic period, the patient's computed tomography (CT) images were converted to STL files using the 3D conversion program. An FDM type 3D printer was used to print 3D airway models from the sub-glottis to the upper carina. ETT size was selected by inserting various sized cuffed-ETTs to a printed 3D airway model.

Official Title
-----------------
Prediction of Endotracheal Tube Size Using a Printed Three-dimensional Airway Model in Pediatric Patients With Congenital Heart Disease: a Prospective, Single-center, Single- Group Study

Conditions
-----------------
Congenital Heart Disease

Intervention / Treatment
-----------------
* Other: intubation with a cuffed ETT by a printed 3D airway model


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children under 6 years of age (range 4 days to 61 months) scheduled for surgery for congenital heart disease with chest computed tomography (CT) images including upper airways Exclusion Criteria: pediatric patients with intubation or tracheostomy before general anesthesia due to underlying disease small sized airway with inner diameter <3.0 mm because of pre-term or low birth weight unstable vital signs during induction history of difficult intubation emergency surgery where printing a 3D airway model in advance was not possible

Ages Eligible for Study
-----------------
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: intubation with a cuffed ETT by a printed 3D airway model|Two anaesthesiologists unaware of patient's demographic data such as patient's height, weight, and age predicted and recorded ETT size by inserting various sized cuffed-ETTs (MallinckrodtTM Hi-Lo tracheal tube, Covidien, Ireland) to a printed 3D airway model. If the diameter of trachea undersized, air leak around ETT can occur. In that case, we can use that ETT after inflating the pilot balloon with small amount of air. Standard monitoring (non-invasive blood pressure measurement, electrocardiogram, and pulse oximetry) was applied to pediatric patients in the operating room and general anesthesia was induced with ketamine 1 mg/kg and rocuronium 0.6 mg/kg and maintained with sevoflurane. After intubation with a cuffed ETT by a printed 3D airway model was finished, an air leak test was performed by one of three anaesthesiologists dedicated to pediatric cardiac anesthesia.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ETT size prediction by the printed 3D airway model | The reliability of ETT size prediction by the printed 3D airway model was compared with the results of the age-based formula. | during anesthesia induction |