An observational study in Airway Management, Tracheal Intubation and Elective Surgeries, sponsored by Samsun University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-05.
Sponsored by Samsun University · Observational
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.
Samsun University is the lead sponsor of 81 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients aged 18 years and older, classified as ASA I to III, who are scheduled to undergo elective surgical procedures under general anesthesia. All participants will require tracheal intubation using either a video laryngoscope or a video laryngeal mask airway (SaCoVLM), both with bougie assistance.
Exclusion Criteria:
Mallampati score ≥ 3
Thyromental distance \< 6 cm
Mouth opening \< 3 cm
Pregnant patients
Tracheal intubation using a video laryngoscope assisted with a bougie in adult patients undergoing elective surgery.
Procedure: Video Laryngeal Mask Airway (SaCoVLM) Intubation with Bougie
Tracheal intubation performed through a video laryngeal mask airway (SaCoVLM) with bougie assistance in adult patients undergoing elective surgery.
Procedure: Video Laryngoscope Intubation with Bougie
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.
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.
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)
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)
Plan to share: Undecided
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Samsun University