Video Laryngeal Mask vs. Endotracheal Tube in Septoplasty

NCT06950957 | Recruiting

• 1 other identifier: GOKEAK 2025/3/15
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (1)

• Glottis/Trachea and Distal Trachea Blood Contamination Scores

  The presence of blood contamination will be evaluated separately at two distinct airway sites: Distal trachea: Both SaCoVLM and ETT groups will undergo fiberoptic bronchoscopic evaluation for blood contamination in the distal trachea immediately before removal of the airway device at the end of surgery. Glottis/tracheal inlet: This area will be visually assessed only in the SaCoVLM group using the integrated camera of the video laryngeal mask immediately prior to device removal at the end of surgery. A standardized 4-point scale will be used for both assessments: 1. = No blood contamination 2. = Mild amount of blood contamination (trace amounts) 3. = Moderate amount of blood contamination 4. = Severe amount of blood contamination

  Evaluated once at the conclusion of surgery, immediately prior to device removal (approximately 60-120 minutes after anesthesia induction).

Secondary Outcomes (13)

• Heart Rate (HR)

  From preoperative baseline until arrival to the recovery unit (approximately 120 minutes).

• Postoperative Sore Throat (POST Score)

  Up to 48 hours postoperatively.

• Arterial Blood Pressure (Systolic, Diastolic, and Mean)

  From preoperative baseline until arrival to the recovery unit (approximately 120 minutes).

• Total Remifentanil Consumption

  Intraoperative

• Airway Insertion Time

  Immediately after induction of anesthesia

Study Arms (2)

VLMA Group

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.

Device: Video Laryngeal Mask Airway (VLMA)

ETT Group

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.

Device: Endotracheal Tube (ETT)

Interventions

Video Laryngeal Mask Airway (VLMA) DEVICE

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.

VLMA Group

Endotracheal Tube (ETT) DEVICE

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.

ETT Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsun University: lead

Study Sites (1)

Samsun University, Samsun Training and Research Hospital

Samsun, Ilkadim, 55000, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• Relevant study comparing LMA and ETT in septoplasty (Karasalan et al., BMC Anesthesiol 2021)

Study Officials

• Hatice Selcuk KUSDERCI, M.D.

  Samsun University

  STUDY DIRECTOR

Central Study Contacts

Hatice Selcuk KUSDERCI, M.D.

CONTACT

+905052159896; drkusderci@hotmail.com

Ahmet Ozan Aydin, M.D.

CONTACT

+905438956146; ahmetozanaydin@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 30, 2025
• Study Start: May 30, 2025
• Primary Completion: November 3, 2025
• Study Completion: December 1, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

TU (1)