Tokyo, April 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061281) titled 'Effects of Device Type and Operator Experience on Nasotracheal Intubation Time' on April 16.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Kagoshima University Hospital

Condition: Condition - Patients undergoing dental and oral and maxillofacial surgery under general anesthesia in whom nasotracheal intubation was clinically indicated Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to prospectively compare intubation time among three devices - video laryngoscopes, direct laryngoscopes, and fiberoptic bronchoscopes - when used as the first line device for nasotracheal intubation in adult patients undergoing dental and oral and maxillofacial surgery under general anesthesia. In addition, the study will evaluate the association of device type with complications, including bleeding and postoperative hoarseness, as well as operator experience. Currently, there are no clearly established criteria for device selection in nasotracheal intubation, and the choice is largely dependent on operator experience and institutional practice. This may result in prolonged intubation time and an increased risk of complications. By clarifying the efficiency and safety profiles of each device, this study aims to provide objective evidence to guide the selection of the initial device in routine clinical practice. In particular, this study will examine whether video laryngoscopes reduce intubation time compared with direct laryngoscopes, and whether fiberoptic bronchoscopes reduce complications such as bleeding and postoperative hoarseness. Furthermore, the relationship between device performance and operator experience will be evaluated to inform appropriate training strategies. This study is expected to contribute to the optimization of device selection in nasotracheal intubation and to improve the quality and safety of perioperative airway management. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - This study is a prospective interventional comparative study using three types of intubation devices: video laryngoscopes, direct laryngoscopes, and fiberoptic bronchoscopes.

Eligible patients will be randomly assigned to one of the three devices using computer-generated allocation. If a video laryngoscope is assigned, intubation will be performed using the video laryngoscope, with up to three attempts permitted. If intubation is unsuccessful after three attempts, subsequent management will be determined at the discretion of the attending anesthesiologist. Perioperative management other than intubation will follow standard clinical practice. Interventions/Control_2 - This study is a prospective interventional comparative study using three types of intubation devices: video laryngoscopes, direct laryngoscopes, and fiberoptic bronchoscopes.

Eligible patients will be randomly assigned to one of the three devices using computer-generated allocation. If a direct laryngoscope is assigned, intubation will be performed using the direct laryngoscope, with up to three attempts permitted. If intubation is unsuccessful after three attempts, subsequent management will be determined at the discretion of the attending anesthesiologist. Perioperative management other than intubation will follow standard clinical practice.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Adult patients aged 18 years or older Patients undergoing dental and oral and maxillofacial surgery under general anesthesia Patients in whom nasotracheal intubation is clinically indicated Patients who provide written informed consent Key exclusion criteria - Patients with nasal obstruction, deformity, or asymmetry identified on CT or panoramic radiography Patients with anticipated difficult intubation Patients at high risk of bleeding, including those with coagulation disorders or receiving anticoagulant therapy Patients judged to be unsuitable for safe participation in the study Target Size - 162

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 02 Month 05 Day Date of IRB - 2026 Year 03 Month 23 Day Anticipated trial start date - 2026 Year 04 Month 16 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069995

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