Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
Healthy Volunteers
ID06825910

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

Age: 18Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • ASA I-II
  • Patients older than 18 years
  • Procedures in supine and lithotomy position
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

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)

Post-operative Follow-up

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

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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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