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

NCT06884592 | Recruiting

• 1 other identifier: NSD2025
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasal Septum, Irregular; Nasal Septal Defect; Difficult Airway; Difficult Endotracheal Intubation; Predicted Difficult Airway

Keywords

Septoplasty; Nasal Septum Deviation; Difficult Airway; Predicted Difficult Airway

Outcome Measures

Primary Outcomes (1)

• Cormack-Lehane laryngeal view scale

  The anaesthesiologist's assessment is based on the laryngoscopic view of Cormack-Lehane. The Cormack- Lehane test categorises the following grades: Grade I: Entire glottis is visible; Grade II: Glottis partially visible; Grade III: Only the epiglottis is visible; Grade IV: Epiglottis also not visible Grade III and IV are considered difficult intubation.

  3 interventions during procedure

Study Arms (1)

Difficult Airway in Septoplasty

The American Society of Anesthesiologists (ASA) I and II patients (aged 18-65 years) with a medical indication for septoplasty under general anaesthesia (requiring tracheal intubation) due to nasal obstruction caused by a deviated nasal septum.

Procedure: Difficult Intubation

Interventions

Difficult Intubation PROCEDURE

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

Also known as: Predicted Difficult Airway

Difficult Airway in Septoplasty

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with nasal congestion due to deviated nasal septum who will undergo septoplasty surgery under general anaesthesia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Başakşehir, Istanbul, 34480, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Demet Altun, Achmet Ali, Levent Aydemir, Nil Kırşan, Mukadder Orhan Sungur, Emre Çamcı Determination of the Difficult Intubation Incidence and its Affecting Factors in Patients Undergoing Septal Deviation Surgery Prospective Controlled Trial DOI:10.14744/scie.2019.55477 South.Clin.Ist. Euras.2020;31(1):1-7

  BACKGROUND

• Dr.Neha Sharma, Dr.Suman Shekhar Tiwari, Dr.Anurag Srivastava, Dr.Prakriti Gupta The preoperative evaluation of risk variables associated with difficult intubation International Journal of Life Sciences Biotechnology and Pharma Research Vol. 12, No. 2, April- June 2023 ISSN: 2250-3137

  BACKGROUND

• Karakus O, Kaya C, Ustun FE, Koksal E, Ustun YB. [Predictive value of preoperative tests in estimating difficult intubation in patients who underwent direct laryngoscopy in ear, nose, and throat surgery]. Rev Bras Anestesiol. 2015 Mar-Apr;65(2):85-91. doi: 10.1016/j.bjan.2014.05.011. Epub 2014 Nov 28. Portuguese.

  PMID: 25435415 BACKGROUND

• Mathangi K, Mathews J, Mathangi CD. Assessment of perioperative difficult airway among undiagnosed obstructive sleep apnoea patients undergoing elective surgery: A prospective cohort study. Indian J Anaesth. 2018 Jul;62(7):538-544. doi: 10.4103/ija.IJA_158_18.

  PMID: 30078857 BACKGROUND

Related Links

• The National Center for Biotechnology Information advances science and health by providing access to biomedical and genomic information. And Southern Clinics of Istanbul Eurasia

Study Officials

• EMINE OZCAN, Anesthesiologist

  Başakşehir Çam ve Sakura Şehir Hastanesi

  PRINCIPAL INVESTIGATOR

• HILAL AKÇA, Anesthesiologist

  Başakşehir Çam ve Sakura Şehir Hastanesi

  STUDY CHAIR

Central Study Contacts

EMINE OZCAN, Anesthesiologist

CONTACT

+905301592856; dr.emine3419@gmail.com

HILAL AKÇA, Anesthesiologist

CONTACT

+905548421509; drhllbs@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Physician

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 19, 2025
• Study Start: May 28, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 months after publication of the results

Locations

TU (1)