How often intubation is difficult during septoplasty and what predicts it
Determination of the Incidence of Difficult Intubation and Predictive Factors in Patients Undergoing Nasal Septum Deviation Surgery.
Başakşehir Çam & Sakura City Hospital · NCT06884592
This will see how often intubation is difficult and which preoperative features predict it in adults aged 18–65 having septoplasty under general anaesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Başakşehir Çam & Sakura City Hospital (other gov) |
| Locations | 1 site (Başakşehir, Istanbul) |
| Trial ID | NCT06884592 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational cohort of ASA I–II adults (18–65) undergoing septoplasty with tracheal intubation at Başakşehir Çam & Sakura City Hospital. Researchers will record the incidence of difficult intubation events and analyze preoperative airway assessments and patient factors to identify predictors. Patients with prior difficult intubation, facial trauma, congenital craniofacial deformity, or difficult mask ventilation are excluded, and no additional interventions or medications are given beyond routine care. The goal is to use these findings to guide preoperative planning and reduce complications related to unexpected difficult airways.
Who should consider this trial
Good fit: Adults 18–65 with nasal obstruction from a deviated septum who are ASA I–II, consent to participate, will receive general anaesthesia with tracheal intubation for septoplasty, and have expected easy mask ventilation are ideal candidates.
Not a fit: Patients with a history of difficult intubation, prior facial trauma or congenital craniofacial deformity, ASA IV–V, or those not undergoing septoplasty under general anaesthesia are excluded and will not directly benefit from this study's findings.
Why it matters
Potential benefit: If successful, the findings could help clinicians predict and prepare for difficult intubation during septoplasty, reducing airway-related complications and improving patient safety.
How similar studies have performed: While prior work links septal deviation to upper airway problems and shows septoplasty can improve airflow, systematic studies measuring the incidence and specific preoperative predictors of difficult intubation in septoplasty patients appear to be lacking, so this approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Başakşehir, Istanbul
- Başakşehir Çam and Sakura City Hospital — Başakşehir, Istanbul, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: EMINE OZCAN, Anesthesiologist — Başakşehir Çam ve Sakura Şehir Hastanesi
- Study coordinator: EMINE OZCAN, Anesthesiologist
- Email: dr.emine3419@gmail.com
- Phone: +905301592856
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nasal Septum, Irregular, Nasal Septal Defect, Difficult Airway, Difficult Endotracheal Intubation, Predicted Difficult Airway, Septoplasty, Nasal Septum Deviation