Clinical trial NCT06950957: Video Laryngeal Mask vs. Endotracheal Tube in Septoplasty
Official title: Comparison of Video Laryngeal Mask Airway and Endotracheal Tube Use for Airway Safety in Patients Undergoing Septoplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Airway Complication of Anesthesia
Anesthesia Intubation Complication
Septoplasty
Keywords: Septoplasty
Laryngeal Mask Airway
Endotracheal Tube
Postoperative Sore Throat
Airway Leak
Otorhinolaryngology Surgery
Supraglottic Airway Devices
Aldrete Score
Postoperative Sore Throat (POST Score)
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes adult patients (aged 18-65 years) undergoing elective septoplasty under general anesthesia. Participants are classified as ASA I-II and are randomly assigned to the VLMA or ETT groups. Patients with anticipated difficult airway, high BMI (\>30), GERD, or pregnancy are excluded

Brief 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.

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

Primary outcomes:
measure: Glottis/Trachea and Distal Trachea Blood Contamination Scores
timeFrame: Evaluated once at the conclusion of surgery, immediately prior to device removal (approximately 60-120 minutes after anesthesia induction).
Secondary outcomes:
measure: Heart Rate (HR)
timeFrame: From preoperative baseline until arrival to the recovery unit (approximately 120 minutes).
measure: Postoperative Sore Throat (POST Score)
timeFrame: Up to 48 hours postoperatively.
measure: Arterial Blood Pressure (Systolic, Diastolic, and Mean)
timeFrame: From preoperative baseline until arrival to the recovery unit (approximately 120 minutes).
measure: Total Remifentanil Consumption
timeFrame: Intraoperative
measure: Airway Insertion Time
timeFrame: Immediately after induction of anesthesia
measure: Intraoperative Airway Complications
timeFrame: From induction of anesthesia to extubation (intraoperative period)
measure: Postoperative Dysphagia (Swallowing Difficulty)
timeFrame: Up to 48 hours postoperatively.
measure: First-Attempt Success Rate of Airway Device Insertion
timeFrame: Immediately after induction of anesthesia.
measure: Postoperative Nausea and Vomiting (PONV)
timeFrame: Up to 48 hours postoperatively.
measure: Airway Pressure Parameters (Peak and Mean Airway Pressure)
timeFrame: From 1 minute to 30 minutes after airway device placement.
measure: Anesthesia Duration
timeFrame: Intraoperative period (approximately 60-120 minutes)
measure: Surgical Duration
timeFrame: Intraoperative period (approximately 30-120 minutes)
measure: Postoperative Laryngospasm and Bronchospasm
timeFrame: Within 24 hours post-extubation
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun University, Samsun Training and Research Hospital
state: Ilkadim
Study officials:
affiliation: Samsun University
name: Hatice Selcuk KUSDERCI, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.