NCT06950957

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 64 (estimated)
• Sponsor: Samsun University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This prospective, randomized controlled trial will compare the efficacy and safety of a video laryngeal mask airway (VLMA) versus a standard endotracheal tube (ETT) for airway management in adult patients (aged 18-65, ASA physical status I-II) undergoing elective septoplasty under general anesthesia. Participants will be randomly assigned to receive either a video-assisted supraglottic airway (VLMA) or a conventional endotracheal tube (ETT). The primary objective is to evaluate whether VLMA can provide better protection against blood contamination in the glottic and subglottic regions compared to ETT. Secondary objectives include assessments of perioperative hemodynamic stability, respiratory performance, postoperative airway-related complications, and overall recovery. All patients will undergo standardized anesthesia induction (e.g., propofol plus an opioid) and maintenance with inhalational agents and/or remifentanil infusion. Depth of anesthesia will be monitored using the bispectral index (BIS), along with standard ASA monitoring. Respiratory parameters (tidal volume, end-tidal CO₂, peak and plateau airway pressures) will be recorded throughout the procedure. Hemodynamic data (heart rate, systolic and diastolic arterial pressures) will be measured at predefined time points: pre-induction, post-airway insertion, and post-extubation. At the end of surgery, blood contamination within the airway will be assessed at two anatomical levels: Distal trachea: In both groups, a fiberoptic bronchoscope will be used for evaluation. In the ETT group, the bronchoscope will be inserted through the endotracheal tube before removal. In the VLMA group, the bronchoscope will be passed through the lumen of the VLMA prior to removal. Glottis/tracheal inlet: This region will be assessed only in the VLMA group, using the device's integrated video camera to obtain a direct visual inspection before removal. A standardized four-point scale adapted from Kaplan et al. will be used to rate the degree of blood contamination: 1. = No visible blood, 2. = Mild contamination, 3. = Moderate contamination, 4. = Severe contamination with diffuse blood. Following airway device removal, all patients will be transferred to the post-anesthesia care unit (PACU) and monitored until achieving an acceptable Aldrete score. Postoperative airway-related symptoms-such as sore throat, hoarseness, dysphagia, and cough-will be assessed at 2, 8, 12, 24, and 48 hours. Additional data including total anesthesia duration, airway insertion time, and any adverse events (e.g., laryngospasm, bronchospasm, desaturation, or need for airway repositioning) will also be documented. This study aims to determine whether VLMA offers advantages over ETT in terms of airway protection, intraoperative stability, and postoperative comfort in septoplasty surgery.

Conditions

• Airway Complication of Anesthesia
• Anesthesia Intubation Complication
• Septoplasty

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2025-05-30
• Primary completion: 2025-11-03
• Completion: 2025-12-01
• First posted: 2025-04-30
• Last updated: 2025-06-12

Locations

1 site across 1 country: Turkey (Türkiye)