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

StatusCompleted
PhaseNot specified
Started
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Record History

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  1. Notable Lead sponsor: Başakşehir Çam & Sakura City Hospital to Başakşehir Çam & Sakura City Hospital Show 7 more changesShow less
    • Trial completed
    • Final enrollment: 330 participants (planned 300)
    • Primary completion date changed from estimate of Dec 30, 2026 to Sep 15, 2026
    • Study completion date changed from estimate of Jan 30, 2027 to Sep 28, 2026
    • Eligibility criteria expanded, about 13 words
    • Site details revised
    • Publications: details revised at 3 of 4 entries
  2. Notable Primary completion date: May 30, 2026 to Dec 30, 2026
    • Study completion date: May 30, 2026 to Jan 30, 2027
    v3
  3. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: May 3, 2026 to May 30, 2026
    • Study completion date: May 15, 2026 to May 30, 2026
    • Start date changed from estimate of May 3, 2025 to May 28, 2025
    • Site details revised
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06884592
Lead Sponsor Başakşehir Çam & Sakura City Hospital
Conditions
(from sponsor)
Nasal Septum, Irregular, Nasal Septal Defect, Difficult Airway, Difficult Endotracheal Intubation, Predicted Difficult Airway
Enrollment 330 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov