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COMPLETED
NCT06950957

Video Laryngeal Mask vs. Endotracheal Tube in Septoplasty

Sponsor: Samsun University

View on ClinicalTrials.gov

Summary

This single-center, prospective, observational, comparative study evaluated airway management using the SaCoVLM™ video laryngeal mask airway (VLMA) and a conventional endotracheal tube (ETT) in adult patients undergoing elective septoplasty under general anesthesia. The airway device was selected by the responsible anesthesiologist as part of routine clinical practice, without randomization. The primary outcome was airway blood contamination assessed at the end of surgery. Secondary outcomes included hemodynamic responses, ventilation parameters, airway device placement characteristics, recovery time, surgeon satisfaction, and postoperative airway-related symptoms. Distal tracheal blood contamination was assessed using flexible bronchoscopy in both groups. Postoperative sore throat, dysphagia, cough, and hoarseness were evaluated during recovery and at predetermined postoperative intervals. Comparative analyses of postoperative symptoms were limited to the first 12 hours because 24-hour follow-up data were incomplete.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

70

Start Date

2025-04-30

Completion Date

2025-11-04

Last Updated

2026-10-22

Healthy Volunteers

No

Interventions

DEVICE

Video Laryngeal Mask Airway (VLMA)

The SaCoVLM™ video laryngeal mask airway, a supraglottic airway device with an integrated camera, was used for airway management during elective septoplasty. The integrated camera enabled direct visualization of the glottic inlet and assessment of proximal blood contamination. At the end of surgery, distal tracheal blood contamination was assessed using flexible bronchoscopy in all 32 VLMA patients included in the final analysis, regardless of proximal blood contamination findings. Airway insertion characteristics, ventilation and hemodynamic parameters, recovery outcomes, and postoperative airway morbidity were recorded.

DEVICE

Endotracheal Tube (ETT)

A conventional cuffed endotracheal tube was inserted using direct laryngoscopy for airway management during elective septoplasty. At the end of surgery, the distal trachea was examined for blood contamination using flexible bronchoscopy through the ETT before removal. Proximal tracheal/glottic contamination was assessed indirectly by examining blood around the distal portion of the ETT cuff after aspiration of the posterior oropharynx and extubation. Airway insertion characteristics, ventilation and hemodynamic parameters, recovery outcomes, and postoperative airway morbidity were recorded.

Locations (1)

Samsun University, Samsun Training and Research Hospital

Samsun, Ilkadim, Turkey (Türkiye)