LMA Protector vs I-Gel in Low-Flow Anesthesia for Laparoscopic Cholecystectomy (NCT07707440) | Clinical Trial Compass
CompletedNot Applicable
LMA Protector vs I-Gel in Low-Flow Anesthesia for Laparoscopic Cholecystectomy
Turkey (Türkiye)62 participantsStarted 2020-07-01
Plain-language summary
This prospective randomized study aims to compare two second-generation supraglottic airway devices (SGAs), the I-Gel and the laryngeal mask airway (LMA) Protector, in patients undergoing laparoscopic cholecystectomy under low-flow desflurane anesthesia. The study evaluates the devices in terms of respiratory mechanics (dynamic compliance, peak inspiratory pressure, plateau pressure, and airway resistance), non-invasive perfusion parameters (oxygen reserve index, perfusion index, and pleth variability index), hemodynamic stability, ease of insertion, oropharyngeal leak pressure, and postoperative complication rates.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged 18-65 years
* American Society of Anesthesiologists (ASA) physical status I or II
* Scheduled for elective laparoscopic cholecystectomy
Exclusion Criteria:
* Known or predicted difficult airway or history of difficult intubation
* Body Mass Index (BMI) greater than 35 kg/m²
* High risk of gastroesophageal reflux or aspiration
* Severe cardiac, respiratory, renal, or hepatic disease
* Pregnancy
* Patient refusal to participate
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dynamic Lung Compliance (Cdyn)
Timeframe: Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
Trial details
NCT IDNCT07707440
SponsorFatih Sultan Mehmet Training and Research Hospital