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

NCT07057908 | Not Yet Recruiting

• 1 other identifier: GOKAEK 2025/10/1
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Airway Management; Tracheal Intubation; Elective Surgeries; Videolaryngoscopy; Anaesthesia

Keywords

Video Laryngoscope; Video Laryngeal Mask Airway; SaCoVLM; Intubation Success Rate; Observational Study; Elective Surgical Patients

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• First-Attempt Intubation Success Rate

  Immediately after intubation

• Insertion-Related Complications

  Intraoperative and early postoperative period (0-30 minutes)

Study Arms (2)

Video Laryngoscope

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

Video Laryngeal Mask Airway (SaCoVLM)

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

Interventions

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.

Video Laryngeal Mask Airway (SaCoVLM)

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.

Video Laryngoscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsun University: lead

Study Sites (1)

Samsun University, Samsun Training and Research Hospital

Samsun, Ilkadim, 55000, Turkey (Türkiye)

Location

Related Publications (3)

• 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 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.

  PMID: 9754506 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.

  PMID: 34869469 BACKGROUND

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Hatice S Kuşderci

  Samsun University Faculty of Medicine, Department of Anesthesiology and Reanimation

  STUDY DIRECTOR

Central Study Contacts

Mehmet Göhan Taflan

CONTACT

+90 535 211 40 70; drmehmettaflan@gmail.com

Ahmet Ozan Aydın

CONTACT

+90 543 895 61 46; ahmetozanaydin@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 10, 2025
• Study Start: September 1, 2025
• Primary Completion: February 2, 2026
• Study Completion: March 2, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

TU (1)