Comparison of I-gel and SaCoVLM in Laparoscopic Cholecystectomy

Comparison of Airway Performance Between I-gel and SaCoVLM in Patients Undergoing Elective Laparoscopic Cholecystectomy: A Prospective Observational Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemodynamic Monitoring; End Tidal Carbon Dioxide; Laryngeal Mask Success Rate

Detailed Description

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 (Estimated): 80

Contacts and Locations

• Study Contact: Name: Hatice Selçuk Kuşderci; Phone Number: 505 215 98 96; Email: drkusderci@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Age between 18 and 70 years.
• American Society of Anesthesiologists (ASA) physical status I-III.
• Patients scheduled for elective laparoscopic cholecystectomy.
• Patients undergoing general anesthesia.
• Patients who provide written informed consent.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Samsun University
• Investigators: Study Director: Hatice Selçuk Kuşderci, Samsun University

Study record dates

Study Major Dates

• Study Start (Estimated): June 24, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: July 2, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: GOKAEK 2026/11/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No