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NCT Number: NCT07692139

Comparison of I-gel and SaCoVLM in Laparoscopic Cholecystectomy

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.

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Key information

Conditions

Hemodynamic Monitoring End Tidal Carbon Dioxide Laryngeal Mask Success Rate

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. Oropharyngeal Leak Pressure (OLP)

    Time frame: After device insertion and after pneumoperitoneum creation during surgery.

    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..

Secondary outcomes

  1. First-Attempt Insertion Success Rate

    Time frame: During device insertion procedure

    The proportion of patients in whom the supraglottic airway device is successfully inserted on the first attempt.

  2. Device Insertion Time

    Time frame: During device insertion procedure

    The time required for successful placement of the supraglottic airway device, measured from device insertion into the oral cavity until effective ventilation is achieved.

  3. Gastric Tube Insertion Success Rate

    Time frame: Immediately following successful placement of the supraglottic airway device before initiation of mechanical ventilation

    The proportion of patients in whom the gastric tube is successfully inserted through the gastric drainage channel of the device.

  4. Peak Airway Pressure (PAP)

    Time frame: 5 minutes after pneumoperitoneum is established.

    Peak airway pressure values measured during mechanical ventilation and compared between study groups

  5. End-Tidal Carbon Dioxide (EtCO₂)

    Time frame: Throughout laparoscopic surgery.

    End-tidal carbon dioxide values measured during surgery and compared between study groups.

  6. 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.

    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

  7. Postoperative Sore Throat

    Time frame: Within 24 hours after surgery.

    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)

  8. Hoarseness

    Time frame: Within 24 hours after surgery.

    The incidence of postoperative dysphagia following airway device use.

  9. Blood Staining and Mucosal Trauma

    Time frame: Immediately after device removal.

    The incidence of blood staining on the device and evidence of mucosal trauma after device removal.

Study contacts

Contact information is provided by the study sponsor or research team.

Hatice Selçuk Kuşderci

CONTACT

[email protected]

505 215 98 96

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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