Actively Recruiting
Comparison Between the I-gel and Protector Supraglottic Airway Devices in Patients Under General Anesthesia
Led by Nikolopoulou Maria Zozefin · Updated on 2025-06-27
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the learning curves of two different laryngeal mask airway (LMA) devices, the I-gel and the Protector, by comparing how anesthesiology residents place them in adult patients. The study focuses on airway management during general anesthesia and aims to understand the time and ease of device placement. Adults participating in the study will be randomly assigned to receive either the LMA Igel or LMA Protector device during surgery. The devices will be inserted intraoperatively while patients are under general anesthesia. Placement attempts will be timed from when the clinician picks up the device until the first capnography waveform appears, with up to three attempts allowed per patient. Participants will be closely monitored during the placement attempts, with documentation of any adverse events occurring during this time. The primary measure is the time required for successful placement. The study includes adult patients aged 18 to 90 years with specific health and anatomical criteria, and participation involves monitoring during surgery. The study is expected to conclude by September 2025.
CONDITIONS
Brief Title
Comparison Between the I-gel and Protector Supraglottic Airway Devices
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 receive insertion of either the LMA Igel or LMA Protector device during general anesthesia.
1 intraoperative visit
Trial Site Locations
Total: 1 location
1
SismanoglioGH
Athens, Attica, Greece, 15126
Actively Recruiting
Research Team
M
Maria Zozefin Nikolopoulou
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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