Comparison of I-gel and SaCoVLM in Laparoscopic Cholecystectomy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorSamsun University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 2 trial groupsGroup A: Group I: i-gel group
Group B: Grup II: SaCoVLM
Trial outcomes
Primary outcomes
1
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..
Time frame
After device insertion and after pneumoperitoneum creation during surgery.Secondary outcomes
1
First-Attempt Insertion Success Rate
The proportion of patients in whom the supraglottic airway device is successfully inserted on the first attempt.
Time frame
During device insertion procedure2
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.
Time frame
During device insertion procedure3
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.
Time frame
Immediately following successful placement of the supraglottic airway device before initiation of mechanical ventilation4
Peak Airway Pressure (PAP)
Peak airway pressure values measured during mechanical ventilation and compared between study groups
Time frame
5 minutes after pneumoperitoneum is established.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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