Tokyo, Oct. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059566) titled 'Effect of Anesthesia Simulation Training Using a 3D-Printed Tracheal Model with Esophageal Atresia : A Pre-Post Study' on Oct. 28.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Matsudo City General Hospital

Condition: Condition - Not applicable (Educational study targeting anesthesiologists, not patients Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study evaluate the effectiveness of simulation-based training using a 3D-printed tracheal model with esophageal atresia to help anesthesiologists acquire the skills for tracheoesophageal fistula closure and neonatal airway management. The educational effectiveness of this program will be evaluated in terms of improvement in technical performance and self-efficacy. Demonstrating the usefulness of this 3D model-based simulation training may contribute to enhancing specialized anesthesia education, supplementing limited clinical opportunities, improving residents' technical skills, and ultimately promoting patient safety. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Simulation-based education will be conducted using a 3D-printed tracheal model simulating esophageal atresia with tracheoesophageal fistula. The educational program consists of three stages: Didactic lecture (about 15 min): Explanation of the anatomy relevant to tracheoesophageal fistula closure, anesthesia management, and procedural overview. Hands-on training (about 30 min): Small-group instruction with a 1:2 instructor-to-trainee ratio using the 3D-printed airway model. Assessment (before and after hands-on training): Participants perform balloon-catheter closure of the tracheoesophageal fistula; procedures are video recorded. Two blinded assessors grade the recordings using the Global Rating Scale (maximum score 35). Educational effect will be analyzed by comparing evaluation scores before vs. after the hands-on training.

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Anesthesiologists who have no prior clinical experience in tracheoesophageal fistula closure using a balloon catheter Able to participate in the educational program during the study period Provided written informed consent after receiving a full explanation of the study Key exclusion criteria - Individuals who declined to provide written informed consent Those who have previously participated in similar tracheoesophageal fistula closure training Those unable to participate in the educational program during the study period Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 23 Day Date of IRB - 2025 Year 09 Month 25 Day Anticipated trial start date - 2025 Year 10 Month 16 Day Last follow-up date - 2025 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067934

Disclaimer: Curated by HT Syndication.