Comparison Between the I-gel and Protector Supraglottic Airway Devices

June 26, 2025 updated by: Nikolopoulou Maria Zozefin

Comparison Between the I-gel and Protector Supraglottic Airway Devices in Patients Under General Anesthesia

This study aims to compare the learning curves of two different laryngeal mask airway devices, by evaluating their placement in adult patients performed by anesthesiology residents

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • ASA I-II
  • Patients older than 18 years
  • Procedures in supine and lithotomy position

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LMA Igel group
Device: LMA Igel
adults allocated to the LMA Igel group, an LMA Igel device will be inserted intraoperatively
Active Comparator: LMA Protector group
Device: LMA Protector
adults allocated to the LMA Protector group, an LMA Protector device will be inserted intraoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The time required for successful placement of the device
Time Frame: Measured from the moment the clinician picks up the LMA device after induction of general anesthesia until the appearance of the first capnography waveform on the monitor with a maximum duration of 60 seconds per attempt and up to three attempts allowed
Measured from the moment the clinician picks up the LMA device after induction of general anesthesia until the appearance of the first capnography waveform on the monitor with a maximum duration of 60 seconds per attempt and up to three attempts allowed

Secondary Outcome Measures

Outcome Measure
Time Frame
Documentation of adverse events during placement
Time Frame: During the placement attempt
During the placement attempt

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nikolopoulou Maria Zozefin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2025

Primary Completion (Estimated)

September 15, 2025

Study Completion (Estimated)

September 15, 2025

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

June 27, 2025

Last Update Submitted That Met QC Criteria

June 26, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 9254/10-04-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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