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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I: i-gel group | Patients receiving airway management with the i-gel supraglottic airway device | ||
| Grup II: SaCoVLM | Patients receiving airway management with the SaCoVLM supraglottic airway device |
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| Measure | Description | Time Frame |
|---|---|---|
| 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.. | After device insertion and after pneumoperitoneum creation during surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| First-Attempt Insertion Success Rate | The proportion of patients in whom the supraglottic airway device is successfully inserted on the first attempt. | During device insertion procedure |
| Device Insertion Time |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of adult patients aged 18-70 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia at Samsun City Hospital. Eligible patients who provide written informed consent and meet the study inclusion criteria will be consecutively enrolled during the study period.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hatice Selçuk Kuşderci | Contact | 505 215 98 96 | drkusderci@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hatice Selçuk Kuşderci | Samsun University | Study Director |
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The time required for successful placement of the supraglottic airway device, measured from device insertion into the oral cavity until effective ventilation is achieved.
| 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. | 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 | 5 minutes after pneumoperitoneum is established. |
| End-Tidal Carbon Dioxide (EtCO₂) | End-tidal carbon dioxide values measured during surgery and compared between study groups. | Throughout laparoscopic surgery. |
| Hemodynamic Parameters | Hemodynamic variables including heart rate, systolic blood pressure, diastolic blood pressure, and mean arterial pressure will be recorded and compared between groups. | 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) | Within 24 hours after surgery. |
| Hoarseness | The incidence of postoperative dysphagia following airway device use. | 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. | Immediately after device removal. |