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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video Laryngoscope | Tracheal intubation using a video laryngoscope assisted with a bougie in adult patients undergoing elective surgery. |
| |
| Video Laryngeal Mask Airway (SaCoVLM) | Tracheal intubation performed through a video laryngeal mask airway (SaCoVLM) with bougie assistance in adult patients undergoing elective surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intraoperative (from tube passing the upper incisors to the third ETCO₂ waveform) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Immediately after intubation |
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Inclusion Criteria:
Exclusion Criteria:
Mallampati score ≥ 3
Thyromental distance < 6 cm
Mouth opening < 3 cm
Pregnant patients
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mehmet Göhan Taflan | Contact | +90 535 211 40 70 | drmehmettaflan@gmail.com | |
| Ahmet Ozan Aydın | Contact | +90 543 895 61 46 | ahmetozanaydin@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hatice S Kuşderci | Samsun University Faculty of Medicine, Department of Anesthesiology and Reanimation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsun University, Samsun Training and Research Hospital | Samsun | Ilkadim | 55000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27648030 | Background | Sargin M, Uluer MS. Comparison of McGrath((R)) Series 5 video laryngoscope with Macintosh laryngoscope: A prospective, randomised trial in patients with normal airways. Pak J Med Sci. 2016 Jul-Aug;32(4):869-74. doi: 10.12669/pjms.324.10037. | |
| 9754506 | Background | Levitan RM, Ochroch EA, Kush S, Shofer FS, Hollander JE. Assessment of airway visualization: validation of the percentage of glottic opening (POGO) scale. Acad Emerg Med. 1998 Sep;5(9):919-23. doi: 10.1111/j.1553-2712.1998.tb02823.x. |
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| 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. |
|
| 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. | Intraoperative and early postoperative period (0-30 minutes) |
| 34869469 | Background | Sun Y, Huang L, Xu L, Zhang M, Guo Y, Wang Y. The Application of a SaCoVLMTM Visual Intubation Laryngeal Mask for the Management of Difficult Airways in Morbidly Obese Patients: Case Report. Front Med (Lausanne). 2021 Nov 18;8:763103. doi: 10.3389/fmed.2021.763103. eCollection 2021. |
| ID | Term |
|---|---|
| D007440 | Intubation |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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