Actively Recruiting
Laryngeal Mask Airway I-Gel and Laryngeal Mask Airway Protector for Minor Urological Procedures Under General Anesthesia in Adult Patients: A Randomized Comparative Study
Led by Nikolopoulou Maria Zozefin · Updated on 2026-04-27
100
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two types of laryngeal mask airway devices, the iGel and the Protector, in adults undergoing minor urological procedures under general anesthesia. The study focuses on evaluating the devices' effectiveness, safety, and any unwanted effects during these procedures. Participants will be adults who meet specific health criteria and are undergoing surgery in certain positions. Participants will be randomly assigned to one of two groups. One group will receive the iGel device, and the other will receive the Protector device, both inserted during surgery. The study will measure how well each device seals the airway in different head positions and monitor the success rate and time needed for placement, as well as attempts to insert a nasogastric tube through the devices. Throughout the study, participants will be monitored for airway sealing pressure using specific measures shortly after device placement. Their airways will be assessed before surgery for potential difficulties. Researchers will document any adverse events immediately after the procedure. The study will also record the number of attempts and timing for device placement and nasogastric tube insertion. Participation lasts for the duration of the surgical procedure and immediate postoperative monitoring.
CONDITIONS
Brief Title
LMA I-Gel Versus LMA Protector During Minor Urological Procedures Under General Anesthesia in Adult Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ASA I-II
- Patients older than 18 years
- Procedures in supine and lithotomy position
You will not qualify if you...
- Tumors or anatomical anomalies of the upper airway
- Known history of difficult intubation
- Limited mouth opening less than 2cm
- Decreased compliance of the lungs or the thoracic cage
- Need of mechanical ventilation after the surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the surgical procedure
Participants will undergo minor urological procedures under general anesthesia during which one of two laryngeal mask airway devices, the iGel or the Protector, will be inserted intraoperatively.
1 visit (in-person)
Duration - Immediately after the procedure
Participants will be monitored immediately after the procedure for any adverse events and to assess device performance.
1 visit (in-person)
Trial Site Locations
Total: 2 locations
1
SismanoglioGH
Athens, Greece
Not Yet Recruiting
2
SismanoglioGH
Athens, Greece
Actively Recruiting
Research Team
M
Maria Zozefin Nikolopoulou
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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