Health TrialsbyHealthPanel

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

ConditionsAirway ManagementTracheal IntubationElective SurgeriesVideolaryngoscopyAnaesthesia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSamsun University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients younger than 18 years

Patients undergoing emergency surgery

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)

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Video Laryngoscope Intubation with Bougie

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

176 Participants
are divided into 2 treatment groups
Group A: Video Laryngoscope1 intervention
Group B: Video Laryngeal Mask Airway (SaCoVLM)1 intervention

Trial outcomes

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.

Time frame
Intraoperative (from tube passing the upper incisors to the third ETCO₂ waveform)

Secondary outcomes

1

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

Time frame
Immediately after intubation
2

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.

Time frame
Intraoperative and early postoperative period (0-30 minutes)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Samsun University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: