Video Laryngeal Mask vs. Endotracheal Tube in Septoplasty

Condition(s) studied

Investigational drug(s) / intervention(s)

Video 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.

Endotracheal 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.

Study 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

Primary outcome measure(s)

• Glottis/Trachea and Distal Trachea Blood Contamination Scores — Evaluated once at the conclusion of surgery, immediately prior to device removal (approximately 60-120 minutes after anesthesia induction).
  The presence of blood contamination will be evaluated separately at two distinct airway sites: Distal trachea: Both SaCoVLM and ETT groups will undergo fiberoptic bronchoscopic evaluation for blood contamination in the distal trachea immediately before removal of the airway device at the end of surgery. Glottis/tracheal inlet: This area will be visually assessed only in the SaCoVLM group using the integrated camera of the video laryngeal mask immediately prior to device removal at the end of surgery. A standardized 4-point scale will be used for both assessments: 1. = No blood contamination 2. = Mild amount of blood contamination (trace amounts) 3. = Moderate amount of blood contamination 4. = Severe amount of blood contamination

Trial sites (1)

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