NCT06884592 Determination of the Frequency and Predictors of Difficult Intubation in Septoplasty Operations
| NCT ID | NCT06884592 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Başakşehir Çam & Sakura City Hospital |
| Condition | Nasal Septum, Irregular |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-05-28 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-05-28 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Consenting patients, * ASA-I-II * Between the ages of 18 and 65, * Difficult intubation and no history of facial trauma or congenital craniofacial deformity * Patients with easy mask ventilation during the procedure * Nasal obstruction due to deviated nasal septum, * Patients who will receive general anaesthesia and undergo septoplasty surgery Exclusion Criteria: * Patients without consent * Not in the appropriate age range, * Patients who do not receive general anaesthesia and will not undergo septoplasty surgery, * ASA-IV-V with , * Difficult intubation and a history of facial trauma or congenital craniofacial deformity * Patients with easy mask ventilation during the procedure
Contact & Investigator
EMINE OZCAN, Anesthesiologist
PRINCIPAL INVESTIGATOR
Başakşehir Çam ve Sakura Şehir Hastanesi
Frequently Asked Questions
Who can join the NCT06884592 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Nasal Septum, Irregular. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06884592 currently recruiting?
Yes, NCT06884592 is actively recruiting participants. Contact the research team at dr.emine3419@gmail.com for enrollment information.
Where is the NCT06884592 trial being conducted?
This trial is being conducted at Başakşehir, Turkey (Türkiye).
Who is sponsoring the NCT06884592 clinical trial?
NCT06884592 is sponsored by Başakşehir Çam & Sakura City Hospital. The principal investigator is EMINE OZCAN, Anesthesiologist at Başakşehir Çam ve Sakura Şehir Hastanesi. The trial plans to enroll 300 participants.