Comparison of Intubation Using Video Laryngeal Mask and Video Laryngoscope in Elective Surgical Patients
NCT ID: NCT07057908
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
176 participants
OBSERVATIONAL
2025-09-01
2026-03-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Video Laryngoscope
Tracheal intubation using a video laryngoscope assisted with a bougie in adult patients undergoing elective surgery.
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 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.
Video Laryngeal Mask Airway (SaCoVLM)
Tracheal intubation performed through a video laryngeal mask airway (SaCoVLM) with bougie assistance in adult patients undergoing elective surgery.
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.
Interventions
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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.
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 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 Criteria
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Inclusion Criteria
* Patients scheduled for elective surgical procedures
* Patients classified as ASA Physical Status I-III
* Patients undergoing general anesthesia
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Samsun University
OTHER
Responsible Party
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Principal Investigators
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Hatice S Kuşderci
Role: STUDY_DIRECTOR
Samsun University Faculty of Medicine, Department of Anesthesiology and Reanimation
Locations
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Samsun University, Samsun Training and Research Hospital
Samsun, Ilkadim, Turkey (Türkiye)
Countries
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Central Contacts
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References
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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.
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.
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.
Other Identifiers
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GOKAEK 2025/10/1
Identifier Type: -
Identifier Source: org_study_id
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