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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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
• Процедура Video Laryngeal Mask Airway (SaCoVLM) Intubation with Bougie
  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 in

Первичные конечные точки

• Time to Successful Intubation [Срок оценки: Intraoperative (from tube passing the upper incisors to the third ETCO₂ waveform)]

Вторичные конечные точки (2)

• First-Attempt Intubation Success Rate [Срок оценки: Immediately after intubation]
• Insertion-Related Complications [Срок оценки: Intraoperative and early postoperative period (0-30 minutes)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Samsun University, Samsun Training and Research Hospital — Samsun

Публикации

• 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. PMID 27648030
• 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. PMID 9754506
• 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. PMID 34869469

Идентификаторы

NCT: NCT07057908 · GOKAEK 2025/10/1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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