Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
Healthy Volunteers
ID06938308

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

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

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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 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

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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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