Comparison of ease of intubation and epistaxis with Ivory Polyvinylchloride north pole versus Armored tube in patients undergoing head and neck surgery under general anesthesia with video-laryngoscope guided nasotracheal intubation: A randomized parallel arm study.

On the day prior to Surgery, patients who meet the inclusion and exclusion criteria will be identified, provided with a patient information sheet, and have the study protocol explained to them. Informed consent will be obtained after the procedure details are explained. Key preoperative measurements ,including age, gender, body mass index, inter incisor distance, thyromental distance, Mallampati classification, and upper lip bite test, will be recorded, along with the American Society of Anesthesiologist physical grade and planned surgery type . An Otolaryngologist will perform nasal endoscopy to identify a patent nostril, with the right nostril chosen for nasotracheal intubtion if no significant difference is observed. Participants will be randomized into two groups group N and Group A on the day of surgery using a computer-generated random number and allocated via sealed envelopes to ensure concealment. Blinding will be maintained for the patient and data analyst, though blinding the intubating anesthetics will not be possible due to the nature of the study.

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.