This prospective observational study aims to compare the ventilation performance and safety of the i-gel and SaCoVLM supraglottic airway devices in adult patients undergoing elective laparoscopic cholecystectomy. Ventilation-related parameters, airway sealing performance, insertion characteristics, and perioperative complications will be evaluated.
Laparoscopic surgery requires the creation of pneumoperitoneum and frequently involves patient positioning changes, both of which can increase intrathoracic and airway pressures. These physiological changes may affect the performance of supraglottic airway devices and challenge effective ventilation. Second-generation supraglottic airway devices are increasingly used as alternatives to endotracheal intubation in laparoscopic procedures because they provide effective ventilation while reducing airway-related complications. The i-gel is widely used due to its ease of insertion, integrated gastric drainage channel, and favorable safety profile. The SaCoVLM (Video Laryngeal Mask) is a novel supraglottic airway device that enables direct visualization of laryngeal structures during placement, allowing confirmation of optimal positioning and potentially improving airway management. This prospective observational study will compare the i-gel and SaCoVLM in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Ventilation performance, airway sealing pressure, insertion success, ease of placement, hemodynamic responses, and perioperative airway-related complications will be assessed. The findings may provide further evidence regarding the clinical performance and safety of these devices during laparoscopic surgery.
Study Type
OBSERVATIONAL
Enrollment
80
Oropharyngeal Leak Pressure (OLP)
Oropharyngeal leak pressure (OLP) will be measured and compared between the i-gel and SaCoVLM groups to evaluate airway sealing performance during elective laparoscopic cholecystectomy..
Time frame: After device insertion and after pneumoperitoneum creation during surgery.
First-Attempt Insertion Success Rate
The proportion of patients in whom the supraglottic airway device is successfully inserted on the first attempt.
Time frame: During device insertion procedure
Device Insertion Time
The time required for successful placement of the supraglottic airway device, measured from device insertion into the oral cavity until effective ventilation is achieved.
Time frame: During device insertion procedure
Gastric Tube Insertion Success Rate
The proportion of patients in whom the gastric tube is successfully inserted through the gastric drainage channel of the device.
Time frame: Immediately following successful placement of the supraglottic airway device before initiation of mechanical ventilation
Peak Airway Pressure (PAP)
Peak airway pressure values measured during mechanical ventilation and compared between study groups
Time frame: 5 minutes after pneumoperitoneum is established.
End-Tidal Carbon Dioxide (EtCO₂)
End-tidal carbon dioxide values measured during surgery and compared between study groups.
Time frame: Throughout laparoscopic surgery.
Hemodynamic Parameters
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Heart rate (beats per minute \[bpm\]) will be recorded at baseline, immediately after supraglottic airway device placement, 5 minutes after device placement, 5 minutes after pneumoperitoneum, 15 minutes after pneumoperitoneum, and at the end of surgery. Mean heart rate values will be compared between the i-gel and SaCoVLM groups.Systolic blood pressure (millimeters of mercury \[mmHg\]) will be recorded at baseline, immediately after supraglottic airway device placement, 5 minutes after device placement, 5 minutes after pneumoperitoneum, 15 minutes after pneumoperitoneum, and at the end of surgery. Mean systolic blood pressure values will be compared between the i-gel and SaCoVLM groups.Mean arterial pressure (millimeters of mercury \[mmHg\]) will be recorded at baseline, immediately after supraglottic airway device placement, 5 minutes after device placement, 5 minutes after pneumoperitoneum, 15 minutes after pneumoperitoneum, and at the end of surgery. Mean arterial pressure values will be
Time frame: Baseline, immediately after device placement, 5 minutes after device placement, 5 minutes after pneumoperitoneum, 15 minutes after pneumoperitoneum, and at the end of surgery.
Postoperative Sore Throat
The incidence of postoperative sore throat following removal of the supraglottic airway device.Postoperative sore throat severity assessed using an 11-point Numeric Rating Scale (NRS)
Time frame: Within 24 hours after surgery.
Hoarseness
The incidence of postoperative dysphagia following airway device use.
Time frame: Within 24 hours after surgery.
Blood Staining and Mucosal Trauma
The incidence of blood staining on the device and evidence of mucosal trauma after device removal.
Time frame: Immediately after device removal.