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

NCT ID: NCT07057908

Last Updated: 2025-09-05

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-03-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Airway Management Tracheal Intubation Elective Surgeries Videolaryngoscopy Anaesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type 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.

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

Intervention Type 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.

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsun University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Mehmet Göhan Taflan

Role: CONTACT

+90 535 211 40 70

Ahmet Ozan Aydın

Role: CONTACT

+90 543 895 61 46

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.

Reference Type BACKGROUND
PMID: 27648030 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9754506 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34869469 (View on PubMed)

Other Identifiers

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GOKAEK 2025/10/1

Identifier Type: -

Identifier Source: org_study_id

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