3D Airway Model for Pediatric Patients

Congenital Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04814888
• Other study ID #: 05-2019-116
• Status: Completed
• Start date: September 3, 2019
• Est. completion date: March 16, 2020

Study information

• Verified date: May 2023
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 16, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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