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
Sponsor study identifier
observational
35
1 country
1
Study Start
September 3, 2019
Actual (reported)Primary Completion
March 16, 2020
Actual (reported)Study Completion
March 16, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 16, 2020
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 3, 2019
Actual (reported)March 16, 2020
Actual (reported)March 16, 2020
Actual (reported)March 22, 2021
Actual (reported)March 24, 2021
Actual (reported)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
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.
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We enrolled 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 from September 3, 2019, to March, 16, 2020. Pediatric patients with congenital heart disease were chosen because they usually keep their ETT with mechanical ventilation in the intensive care unit and also have relatively high risk of complication associated with ETT comparing to healthy patients. Therefore, we think it is more important to select appropriate size of ETT in pediatric patients with congenital heart disease.
Pusan National University Yangsan Hospital
Yangsan, South Korea
Hee Young Kim
Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University
35 participants (actual enrollment reported by the registry).
First Submitted
March 22, 2021
First Posted
March 24, 2021
Study Start
September 3, 2019
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
March 16, 2020
Actual (reported)Study Completion
March 16, 2020
Actual (reported)Last Updated
August 12, 2024
Record last verified: 2024-08
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