End Tidal Carbon Dioxide, Hemodynamic Monitoring, Laryngeal Mask Success Rate
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Samsun University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oropharyngeal Leak Pressure (OLP) | 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
| Measure | Time frame | Description |
|---|---|---|
| First-Attempt Insertion Success Rate | During device insertion procedure | The proportion of patients in whom the supraglottic airway device is successfully inserted on the first attempt. |
| Device Insertion Time | 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. |
| Gastric Tube Insertion Success Rate | 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. |
| Peak Airway Pressure (PAP) | 5 minutes after pneumoperitoneum is established. | Peak airway pressure values measured during mechanical ventilation and compared between study groups |
| End-Tidal Carbon Dioxide (EtCO₂) | Throughout laparoscopic surgery. | End-tidal carbon dioxide values measured during surgery and compared between study groups. |
| Hemodynamic Parameters | 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 |
| Postoperative Sore Throat | 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) |
| Hoarseness | Within 24 hours after surgery. | The incidence of postoperative dysphagia following airway device use. |
| Blood Staining and Mucosal Trauma | Immediately after device removal. | The incidence of blood staining on the device and evidence of mucosal trauma after device removal. |
Contacts
CONTACTHatice Selçuk Kuşderci
STUDY_DIRECTORHatice Selçuk Kuşderci
Samsun University
Outcome results
None listed