LMA I-Gel Versus LMA Protector During Minor Urological Procedures Under General Anesthesia in Adult Patients

Laryngeal Mask Airway I-Gel and Laryngeal Mask Airway Protector for Minor Urological Procedures Under General Anesthesia in Adult Patients: A Randomized Comparative Study

This will be a randomized comparative study comparing the two supraglottic devices i-gel and Protector, intraoperatively, during minor urological procedures under general anesthesia in adult patient.

Study Overview

• Status: Recruiting
• Conditions: Airway Management; General Anesthesia
• Intervention / Treatment: Device: LMA igel; Device: LMA protector

Detailed Description

This randomized comparative study aims to evaluate the effectiveness, safety, and unwanted effects of two laryngeal mask airway devices, the iGel and the Protector. The study will involve adult patients during minor urological procedures under general anesthesia. Participants will be divided into two groups: in one group will be inserted the iGel laryngeal mask airway, while in the other group will be inserted the Protector laryngeal mask airway.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Zozefin Nikolopoulou; Phone Number: +306987389354; Email: mz.nikolopoulou@gmail.com

Study Locations

• Greece
  • Athens, Greece
    • Not yet recruiting
    • SismanoglioGH
    • Contact: Maria Kokolaki; Phone Number: +302132058001; Email: dnths-anaisth@sismanoglio.gr
  • Athens, Greece
    • Recruiting
    • SismanoglioGH
    • Contact: Maria Kokolaki; Phone Number: +302132058001; Email: dnths-anaisth@sismanoglio.gr

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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	Measure Description	Time Frame
Evaluation of the airway sealing pressure of the Laryngeal Mask Airway (LMA) in neutral, extended, and extended-rotated head positions	After the closure of the adjustable pressure limiting valve (APL) of the ventilation machine with a continuous fresh gas flow of 3L/min, a stethoscope for auscultation will be placed to the lateral position of the thyroid cartilage. Leak pressure is defined as the maximum airway pressure (Ppeak) during which no audible sound, like leak, is detected with the placement of the stethoscope at the thyroid cartilage. Successful placement of the laryngeal mask, will be confirmed right after insertion by the auscultation of both hemithoraces, the indication of capnography, and the ratio of inhaled to exhaled pulmonary volume	Leak pressure will be measured in cmH2O within 60 seconds after successful placement: first in the neutral position, second in the extended position, and third in the extended rotated head position

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of each device for patients with a potential difficult airway according to the Simplified Airway Index	The Simplified Airway Risk Index is a multivariate risk score, ranging from 0 to 12 points, thought to estimate the risk of difficult tracheal intubation based on seven parameters. These seven parameters include the mouth opening, where a mouth opening greater than 4 centimeters between the incisors results in 0 points whereas a distance below results in 1 point, the thyromental distance where thyromental distance greater than 6.5 centimeters results in 0 point whereas a distance between 6-6.5 centimeters is given 1 point and finally a distance below 6 centimeters is given 2 points, the mallampati score where Class I and II of the modified mallampati scoring results in 0 points whereas a class III is given 1 point and a class IV 2 points, the movement of the neck where the ability to move the neck more than 90 degrees results in 0 points whereas a movement range of 80-90 degrees results in 1 point and a movement range below 80 degrees results in 2 points, the ability to underbite mean	The patients airway will be evaluated 24 hours before surgery based on the Simplified Airway Index for a potential difficult intubation
The time required for successful placement of the device	This process will involve a maximum of three attempts	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
Number of attempts to successfully place a nasogastric tube through the specially designed channels of the laryngeal mask	The ease of placement will be assessed by counting the number of attempts required to successfully place the nasogastric tube. Success is defined as the ability to place the tube without complications. "Easy" is defined as successful placement on the first attempt, "moderate" as placement on the second attempt, and "difficult" as placement on the third attempt. If placement is not achieved within three attempts, the procedure will be considered unsuccessful. Successful placement will by assessed by the successful suction of gastric fluid	Each attempt, from the moment the clinician picks up the nasogastric tube, will have a time frame of 5 seconds. If the nasogastric tube is not placed within 5 seconds, the attempt will be considered a failure
Documentation of adverse events after the exertion	Complications like blood-stain visible on the LMA after exertion and post-operative sore throat	Immediately after the exertion

Collaborators and Investigators

• Sponsor: Nikolopoulou Maria Zozefin

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: January 12, 2025
• First Submitted That Met QC Criteria: February 9, 2025
• First Posted (Actual): February 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: LMA; Protector; Airway Device Evaluation; iGel; Airway Device Comparison
• Other Study ID Numbers: 19242/29.08.24

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
• product manufactured in and exported from the U.S.: No