Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO

The study focuses on assessing the primary outcome of epistaxis in patients using two different types of tubes: the Portex North Polar Tube (NPT) and a PVC cuffed armored endotracheal tube. Based on previous research by Özkan ASM et al. (2018), which reported an epistaxis incidence of 2.9% for NPT and 22.9% for the armored tube, a sample size calculation determined that 96 patients would be needed (48 per group) to achieve an 80% power at a significance level of 0.05. Factoring in a 10% dropout rate, the study will recruit a total of 100 patients. The earlier study also highlighted that significantly more patients required laryngeal compression (42.9% vs. 11.4%) and changes in head position (45.7% vs. 2.9%) when using the armored tube.

For the study, the intervention devices include the Ivory PVC cuffed nasotracheal tube for Group N and the PVC cuffed armored endotracheal tube for Group A, with intubation performed using a C-MAC video laryngoscope with a D blade. The standardized anesthesia protocol involves pre-operative preparation that includes ensuring fasting guidelines and nasal preparation with 0.1% Xylometazoline. Once in the operating room, wide-bore IV access and standard monitoring (ECG, NIBP, pulse oximetry) will be established. Patients will receive premedication with IV Midazolam, followed by preoxygenation and induction with Fentanyl and Propofol. Rocuronium will be administered as a muscle relaxant before an experienced anesthetist performs the nasotracheal intubation.

During intubation, the lubricated tube will be inserted through the selected nostril, with the video laryngoscope used for guidance. The anesthetist will document any aids used, the time taken for intubation, and any complications encountered. After intubation, hemodynamic parameters will be monitored, and any incidents of nasal or oral bleeding will be recorded. An independent anesthetist will evaluate the intubation difficulty and the incidence of epistaxis five minutes post-intubation. Follow-up assessments will occur 48 hours post-surgery to check for sore throat, hoarseness, and dysphagia. This structured approach aims to rigorously evaluate the safety and efficacy of the two intubation techniques.