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NCT Number: NCT07057908

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsun University, Samsun Training and Research Hospital

Samsun, Ilkadim, 55000, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video Laryngoscope Intubation with Bougie

Procedure

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 Bougie

Procedure

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.

Primary outcomes

  1. Time to Successful Intubation

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

    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.

Secondary outcomes

  1. First-Attempt Intubation Success Rate

    Time frame: Immediately after intubation

    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

  2. Insertion-Related Complications

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmet Ozan Aydın

CONTACT

[email protected]

+90 543 895 61 46

Mehmet Göhan Taflan

CONTACT

[email protected]

+90 535 211 40 70

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Official study title

A Prospective Observational Study Comparing Tracheal Intubation Via Video Laryngeal Mask Airway and Video Laryngoscope in Adult Patients Undergoing Elective Surgery

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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