Comparison of I-gel and SaCoVLM in Laparoscopic Cholecystectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hemodynamic Monitoring, Laryngeal Mask Success Rate, End Tidal Carbon Dioxide. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Airway Performance Between I-gel and SaCoVLM in Patients Undergoing Elective Laparoscopic Cholecystectomy: A Prospective Observational Study
Overview
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.
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.
Primary outcome measures
- Oropharyngeal Leak Pressure (OLP) [Time frame: After device insertion and after pneumoperitoneum creation during surgery.]
Secondary outcome measures (9)
- First-Attempt Insertion Success Rate [Time frame: During device insertion procedure]
- Device Insertion Time [Time frame: During device insertion procedure]
- Gastric Tube Insertion Success Rate [Time frame: Immediately following successful placement of the supraglottic airway device before initiation of mechanical ventilation]
- Peak Airway Pressure (PAP) [Time frame: 5 minutes after pneumoperitoneum is established.]
- End-Tidal Carbon Dioxide (EtCO₂) [Time frame: Throughout laparoscopic surgery.]
- Hemodynamic Parameters [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 [Time frame: Within 24 hours after surgery.]
- Hoarseness [Time frame: Within 24 hours after surgery.]
- Blood Staining and Mucosal Trauma [Time frame: Immediately after device removal.]
Eligibility criteria
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
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07692139 · GOKAEK 2026/11/18