Comparison of Intubation Using Video Laryngeal Mask and Video Laryngoscope in Elective Surgical Patients

N/ANot Yet RecruitingNCT07057908

Samsun University176 enrolled

Overview

This study compares two airway devices that are commonly used during elective surgery: the video laryngeal mask airway (VLM) and the video laryngoscope (VLS). Both are part of routine anesthesia practice. Our main focus is to measure how long intubation takes with each device and to see how successful the intubation is. The study does not involve any extra procedures or risks; everything will be carried out as part of normal patient care.

In this prospective observational study, we will compare two airway devices commonly used during elective surgeries: the video laryngeal mask airway (SaCoVLM) and the video laryngoscope. The study will involve adult patients (18 years and older, ASA physical status I-III) scheduled to undergo surgery under general anesthesia at Samsun University Training and Research Hospital. Patients will be assigned to one of two groups. In one group, intubation will be performed using a video laryngoscope; in the other group, a video laryngeal mask will be used. In both groups, tracheal intubation will be carried out with the assistance of a bougie after device placement. The primary outcome of the study will be intubation time, defined as the duration from insertion of the device until successful confirmation of tracheal intubation. Secondary outcomes will include ease of insertion, the need for additional maneuvers, and complications such as desaturation, trauma, or failed attempts. Since both techniques, as well as bougie use, are already part of routine anesthesia practice, no extra interventions or risks will be introduced. The aim of the study is to compare the performance of these two devices under everyday clinical conditions.

Study Type

OBSERVATIONAL

Enrollment

176

Conditions

Airway Management Tracheal Intubation

Interventions

Video Laryngoscope Intubation with BougiePROCEDURE

Participants in this group will undergo tracheal intubation using a video laryngoscope under general anesthesia. After induction, a standard bougie will be advanced through the vocal cords under video guidance, and the endotracheal tube will be railroaded over the bougie into the trachea. The primary outcome will be intubation time, measured from insertion of the device until confirmation of successful tracheal intubation. Additional parameters such as intubation success rate, ease of insertion, and complications (e.g., desaturation, airway trauma, failed attempts) will also be recorded. No extra procedures will be performed beyond routine airway management.

Video Laryngeal Mask Airway (SaCoVLM) Intubation with BougiePROCEDURE

Participants in this group will undergo tracheal intubation using a video laryngeal mask airway (SaCoVLM) under general anesthesia. After successful placement of the device, a standard bougie will be inserted through the SaCoVLM's dedicated lumen, and an endotracheal tube will be advanced over the bougie into the trachea under video guidance. The primary outcome will be intubation time, defined as the duration from device insertion to confirmation of successful intubation. Secondary outcomes include intubation success rate, ease of insertion, and complications such as desaturation, trauma, or failed attempts. As both techniques are part of routine practice, no additional risks will be introduced.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients aged 18 years and older * Patients scheduled for elective surgical procedures * Patients classified as ASA Physical Status I-III * Patients undergoing general anesthesia Exclusion Criteria: * Patients younger than 18 years * Patients undergoing emergency surgery * Patients with difficult airway predictors, such as: Mallampati score ≥ 3 Thyromental distance \< 6 cm Mouth opening \< 3 cm * Patients with anatomical abnormalities or surgical history involving the oropharynx, larynx, or airway * Patients with conditions contraindicating head or neck manipulation (e.g., cervical instability, upper airway tumors) Pregnant patients

Outcomes

Primary Outcomes

Time to Successful Intubation

The time from when the endotracheal tube passes the upper incisors to the appearance of three consecutive end-tidal CO₂ (ETCO₂) waveforms on the capnograph. This will be used as the objective marker of successful tracheal intubation. Timing will be recorded in seconds by an independent observer using a stopwatch.

Time frame: Intraoperative (from tube passing the upper incisors to the third ETCO₂ waveform)

Secondary Outcomes

First-Attempt Intubation Success Rate

Defined as successful tracheal intubation on the first attempt, confirmed by visualization of three consecutive ETCO₂ waveforms and bilateral chest expansion. The outcome will be recorded as a binary variable: Yes = Successful on first attempt No = Failed or required multiple attempts

Time frame: Immediately after intubation

Insertion-Related Complications

Complications related to the airway device or bougie use, including desaturation (SpO₂ \< 92%), oropharyngeal trauma (visible bleeding), or need for additional maneuvers.

Time frame: Intraoperative and early postoperative period (0-30 minutes)