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Comparison Between the I-gel and Protector Supraglottic Airway Devices

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06938308
Enrollment
200
Registered
2025-04-22
Start date
2025-04-22
Completion date
2025-09-15
Last updated
2025-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Management, Learning Curve

Keywords

I-gel, Protector, learning curve, LMA, airway

Brief summary

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

Interventions

DEVICELMA Igel

adults allocated to the LMA Igel group, an LMA Igel device will be inserted intraoperatively

adults allocated to the LMA Protector group, an LMA Protector device will be inserted intraoperatively

Sponsors

Nikolopoulou Maria Zozefin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
The time required for successful placement of the deviceMeasured 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

MeasureTime frame
Documentation of adverse events during placementDuring the placement attempt

Countries

Greece

Contacts

Primary ContactMaria Zozefin Nikolopoulou
mz.nikolopoulou@gmail.com+306987389354

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026