Video Laryngeal Mask vs. Endotracheal Tube in Septoplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Video Laryngeal Mask Airway (VLMA), Endotracheal Tube (ETT).
- Who it may be relevant to
- Registry conditions: Airway Complication of Anesthesia, Anesthesia Intubation Complication, Septoplasty. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison of Video Laryngeal Mask Airway and Endotracheal Tube Use for Airway Safety in Patients Undergoing Septoplasty
Overview
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.
Interventions
- 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 d - 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 differen
Primary outcome measures
- Glottis/Trachea and Distal Trachea Blood Contamination Scores [Time frame: Evaluated once at the conclusion of surgery, immediately prior to device removal (approximately 60-120 minutes after anesthesia induction).]
Secondary outcome measures (12)
- Heart Rate (HR) [Time frame: From preoperative baseline until arrival to the recovery unit (approximately 120 minutes).]
- Postoperative Sore Throat (POST Score) [Time frame: Up to 48 hours postoperatively.]
- Arterial Blood Pressure (Systolic, Diastolic, and Mean) [Time frame: From preoperative baseline until arrival to the recovery unit (approximately 120 minutes).]
- Total Remifentanil Consumption [Time frame: Intraoperative]
- Airway Insertion Time [Time frame: Immediately after induction of anesthesia]
- Intraoperative Airway Complications [Time frame: From induction of anesthesia to extubation (intraoperative period)]
- Postoperative Dysphagia (Swallowing Difficulty) [Time frame: Up to 48 hours postoperatively.]
- First-Attempt Success Rate of Airway Device Insertion [Time frame: Immediately after induction of anesthesia.]
- Postoperative Nausea and Vomiting (PONV) [Time frame: Up to 48 hours postoperatively.]
- Airway Pressure Parameters (Peak and Mean Airway Pressure) [Time frame: From 1 minute to 30 minutes after airway device placement.]
- Anesthesia Duration [Time frame: Intraoperative period (approximately 60-120 minutes)]
- Surgical Duration [Time frame: Intraoperative period (approximately 30-120 minutes)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Samsun University, Samsun Training and Research Hospital — Samsun
Publications
- Kaplan A, Crosby GJ, Bhattacharyya N. Airway protection and the laryngeal mask airway in sinus and nasal surgery. Laryngoscope. 2004 Apr;114(4):652-5. doi: 10.1097/00005537-200404000-00010. PMID 15064618
- Karaaslan E, Akbas S, Ozkan AS, Colak C, Begec Z. A comparison of laryngeal mask airway-supreme and endotracheal tube use with respect to airway protection in patients undergoing septoplasty: a randomized, single-blind, controlled clinical trial. BMC Anesthesiol. 2021 Jan 7;21(1):5. doi: 10.1186/s12871-020-01222-4. PMID 33407130
Identifiers
NCT: NCT06950957 · GOKEAK 2025/3/15