An observational study in Congenital Heart Disease, sponsored by Pusan National University Yangsan Hospital. Completed at 1 site in South Korea. Open to participants aged Up to 5 Years. Per ClinicalTrials.gov, last updated 2024-08-12.
Sponsored by Pusan National University Yangsan Hospital · Observational
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.
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.
1,031 studies on the registry are indexed under Heart Defects, Congenital; 262 are open to participants now.
This study's enrollment of 35 is below the median of 120 across 459 observational studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →Pusan National University Yangsan Hospital is the lead sponsor of 108 studies on the registry; 27 are open to participants now.
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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.
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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.
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.
Time frame: during anesthesia induction
Plan to share: No
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Pusan National University Yangsan Hospital →