RecruitingNCT06950957

Video Laryngeal Mask vs. Endotracheal Tube in Septoplasty

Comparison of Video Laryngeal Mask Airway and Endotracheal Tube Use for Airway Safety in Patients Undergoing Septoplasty


Sponsor

Samsun University

Enrollment

64 participants

Start Date

May 30, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This randomized controlled trial compares a video laryngeal mask airway (VLMA) and an endotracheal tube (ETT) in adult patients undergoing elective septoplasty. The primary objective is to see which device more effectively prevents surgical blood contamination in the glottic and subglottic regions. The study also assesses perioperative hemodynamic stability, ventilation parameters, and postoperative recovery factors such as sore throat, hoarseness, and overall patient comfort. The findings aim to help determine the optimal airway device choice for nasal surgeries.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

  • ASA I-II classification patients
  • Patients aged 18-65 years undergoing elective septoplasty

Exclusion Criteria6

  • ASA III-IV classification patients
  • Patients with anticipated difficult airway
  • Patients under 18 years of age
  • History of gastroesophageal reflux disease (GERD) or hiatal hernia
  • Body mass index (BMI) \>30
  • Pregnant patients

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Interventions

DEVICEVideo Laryngeal Mask Airway (VLMA)

A second-generation supraglottic airway device with an integrated video camera, used for airway management in adult patients undergoing elective septoplasty. The device allows real-time visualization of the glottic inlet to identify blood infiltration or anatomical challenges. Prior to removal, a fiberoptic bronchoscope will be introduced through the device's lumen to assess the distal trachea for blood contamination. Parameters such as airway insertion time, ventilation mechanics, hemodynamic data, analgesic requirements, and postoperative recovery scores (e.g., Aldrete score, sore throat incidence) will be recorded and analyzed.

DEVICEEndotracheal Tube (ETT)

A standard cuffed endotracheal tube inserted using direct laryngoscopy, employed for airway management during elective septoplasty. At the end of surgery, a fiberoptic bronchoscope will be passed through the ETT to evaluate the distal trachea for blood contamination. Airway insertion time, ventilation parameters, intraoperative hemodynamics, analgesic use, and postoperative outcomes (including sore throat and recovery scores) will be documented and compared with the VLMA group to assess differences in airway safety and clinical performance.


Locations(1)

Samsun University, Samsun Training and Research Hospital

Samsun, Ilkadim, Turkey (Türkiye)

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NCT06950957


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