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

NCT06825910 | Recruiting DMC

• 1 other identifier: 19242/29.08.24
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

General Anesthesia; Airway Management

Keywords

LMA; Protector; Airway Device Evaluation; iGel; Airway Device Comparison

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Success rate of each device for patients with a potential difficult airway according to the Simplified Airway Index

  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

  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

  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

  Immediately after the exertion

Study Arms (2)

LMA igel group

ACTIVE COMPARATOR

Device: LMA igel

LMA protector group

ACTIVE COMPARATOR

Device: LMA protector

Interventions

LMA igel DEVICE

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

LMA igel group

LMA protector DEVICE

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

LMA protector group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nikolopoulou Maria Zozefin: lead

Study Sites (2)

SismanoglioGH

Athens, Greece

NOT YET RECRUITING

SismanoglioGH

Athens, Greece

RECRUITING

Central Study Contacts

Maria Zozefin Nikolopoulou

CONTACT

+306987389354; mz.nikolopoulou@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiology Resident at Sismanoglio General Hospital

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: February 13, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)