Comparison of Intubation Using Video Laryngeal Mask and Video Laryngoscope in Elective Surgical Patients
- Conditions
- Airway ManagementTracheal IntubationGlottis VisualizationElective SurgeriesVideolaryngoscopyAnaesthesia
- Registration Number
- NCT07057908
- Lead Sponsor
- Samsun University
- Brief Summary
This study looks at how effective two different tools are for helping patients breathe during elective surgery: a video laryngeal mask airway (VLM) and a video laryngoscope (VLS). Both are already used in daily practice. We'll compare how clearly each tool lets us see the vocal cords and how successful the intubation is. No extra procedures or risks will be added - we're just observing what happens during normal care.
- Detailed Description
In this prospective observational study, we will compare two common airway devices used in elective surgeries: the video laryngeal mask airway (SaCoVLM) and the video laryngoscope. The study will include adult patients (18 years and older) with ASA physical status I-III, scheduled for surgery under general anesthesia at Samsun University Training and Research Hospital.
In this prospective observational study, we will compare two common airway devices used during elective surgeries: the video laryngeal mask airway (SaCoVLM) and the video laryngoscope. The study will include adult patients (aged 18 and older, ASA I-III) undergoing surgery under general anesthesia at Samsun University Training and Research Hospital.
Patients will be randomly 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 the device is placed.
After airway placement, the glottic view will be recorded using the device's integrated video system. The primary outcome will be the Percentage of Glottic Opening (POGO) - a score reflecting how much of the vocal cords can be visualized.
Secondary outcomes will include ease of insertion, whether additional maneuvers are needed, and the presence of complications such as desaturation, trauma, or failed attempts. Since both techniques - and bougie use - are part of routine clinical practice, no additional interventions will be introduced. This study aims to compare the performance of the two systems under real-world conditions.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 176
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glottic View Quality (POGO Score) During intubation (intraoperative, approximately within first 2 minutes) The primary outcome is the quality of the glottic view during intubation, assessed using the Percentage of Glottic Opening (POGO) score. POGO represents the percentage of the glottic aperture visible on video, ranging from 0% (no glottic structures visible) to 100% (full view of the glottic opening). Each procedure will be recorded and scored by two independent anesthesiologists.
- Secondary Outcome Measures
Name Time Method First-Attempt Intubation Success Rate Immediately after intubation 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 attemptsTime to Successful Intubation Intraoperative (from device insertion to third ETCO₂ wave) The time from the insertion of the airway device (VLMA or video laryngoscope) to the appearance of three consecutive end-tidal CO₂ (ETCO₂) waveforms on the capnograph. This is used as an objective marker for successful tracheal placement. Timing will be recorded in seconds by an independent observer using a stopwatch.
Insertion-Related Complications Intraoperative and early postoperative period (0-30 minutes) Complications related to the airway device or bougie use, including desaturation (SpO₂ \< 92%), oropharyngeal trauma (visible bleeding), or need for additional maneuvers.
Trial Locations
- Locations (1)
Samsun University, Samsun Training and Research Hospital
🇹🇷Samsun, Ilkadim, Turkey
Samsun University, Samsun Training and Research Hospital🇹🇷Samsun, Ilkadim, Turkey