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RECRUITING
NCT06884592

Determination of the Frequency and Predictors of Difficult Intubation in Septoplasty Operations

Sponsor: Başakşehir Çam & Sakura City Hospital

View on ClinicalTrials.gov

Summary

Deviated septum is among the most prevalent etiologies of nasal obstruction. Congenital or acquired deformities of the nasal septum have been demonstrated to result in partial obstruction of the airflow, thereby causing respiratory distress. Furthermore, studies have indicated a potential correlation between nasal congestion and Obstructive Sleep Apnoea Syndrome (OSAS). It is a well-documented phenomenon that patients suffering from nasal obstruction often exhibit an open mouth during sleep, a condition that has been shown to result in the narrowing of the pharyngeal lumen and the subsequent development of sleep-related breathing disorders, including snoring and sleep apnoea. Surgical intervention to correct a deviated nasal septum (commonly referred to as septoplasty) has been shown to reduce upper airway resistance by enhancing airflow, leading to a reduction in the severity of both snoring and OSAS. Numerous studies have demonstrated a robust correlation between a deviated nasal septum and asymmetric facial growth, including maxillary and mandibular abnormalities. While septoplasty is considered a minor surgical procedure with a low anaesthetic risk, concomitant obstructive sleep apnoea syndrome (OSAS) and facial asymmetry have been demonstrated to be associated with an increased risk of difficult intubation. Consequently, the development of preoperative assessment tests to predict difficult intubation is imperative for effective planning of the necessary preoperative preparation when such complications are anticipated. The present study therefore sought to evaluate the incidence of difficult airway in patients undergoing septoplasty. The secondary aim was to determine the predictive factors associated with difficult airway in patients undergoing septoplasty.

Official title: Determination of the Incidence of Difficult Intubation and Predictive Factors in Patients Undergoing Nasal Septum Deviation Surgery.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2025-05-28

Completion Date

2026-05-30

Last Updated

2025-05-31

Healthy Volunteers

Yes

Interventions

PROCEDURE

Difficult Intubation

Determination of difficult intubation, according to the Cormack-Lehane scale, intubation will be considered easy for grade I or II and difficult for grade III or IV. If intubation could not be performed with the Macintosh laryngoscope in three attempts, the next step would be to perform intubation with the videolaryngoscope and the third step would be to place the laryngeal mask airway (LMA). The correct position of the tube in the trachea will be confirmed after intubation, preferably by visual confirmation of the tube passing through the glottic opening, auscultation of the chest with a stethoscope and a normal capnograph. If the LMA attempt fails, the patient will be allowed to awaken, with the final step being ventilation using a face mask and consideration of reversing the muscle relaxant effect with sugammadex (4-5 mg/kg). If intubation fails on the first attempt, an intubation stylet will be used if necessary. The intubation method used, total number of attempts for successful i

Locations (1)

Başakşehir Çam and Sakura City Hospital

Başakşehir, Istanbul, Turkey (Türkiye)