3D Airway Model for Pediatric Patients

NCT ID: NCT04814888

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-03
• Study Completion Date: 2020-03-16

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.

Detailed Description

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.

Conditions

Congenital Heart Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

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

• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kim Hee Young

Clinical associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hee Young Kim

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University

Locations

Pusan National University Yangsan Hospital

Yangsan, , South Korea

Countries

South Korea

Other Identifiers

05-2019-116

Identifier Type: -

Identifier Source: org_study_id