Video Laryngeal Mask vs. Endotracheal Tube in Septoplasty

Samsun University

Status: Enrolling

Conditions: Anesthesia Intubation Complication; Airway Complication of Anesthesia; Septoplasty

Treatments: Device: Endotracheal Tube (ETT); Device: Video Laryngeal Mask Airway (VLMA)

Study type: Observational

Funder types: Other

Identifiers

NCT06950957

GOKEAK 2025/3/15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

64 participants in 2 patient groups

VLMA Group

Description:

Participants assigned to this group will receive airway management via a video laryngeal mask airway (VLMA) with an integrated camera system for direct visualization of the laryngeal inlet. The distal tracheal region will also be examined using a fiberoptic bronchoscope introduced through the VLMA lumen prior to device removal, to assess potential blood contamination. Perioperative parameters (e.g., ventilation metrics, hemodynamic data) and postoperative recovery outcomes will be recorded and analyzed.

Treatment:

Device: Video Laryngeal Mask Airway (VLMA)

ETT Group

Description:

Participants in this group will receive airway management using a standard endotracheal tube (ETT) inserted via direct laryngoscopy. At the end of surgery, the distal tracheal region will be examined through the endotracheal tube using a fiberoptic bronchoscope to assess the presence of blood contamination. Perioperative parameters (e.g., ventilation metrics, hemodynamic data) and postoperative recovery outcomes will be recorded and compared with those of the VLMA group.

Treatment:

Device: Endotracheal Tube (ETT)