NCT06938308

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

April 22, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

June 27, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

April 14, 2025

Last Update Submit

June 26, 2025

Conditions

Airway ManagementLearning Curve

Keywords

I-gelProtectorlearning curveLMAairway

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Documentation of adverse events during placement

    During the placement attempt

Study Arms (2)

LMA Igel group

ACTIVE COMPARATOR
Device: LMA Igel

LMA Protector group

ACTIVE COMPARATOR
Device: LMA Protector

Interventions

LMA IgelDEVICE

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

LMA Igel group
LMA ProtectorDEVICE

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

LMA Protector group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SismanoglioGH

Athens, Attica, 15126, Greece

RECRUITING

Central Study Contacts

Maria Zozefin Nikolopoulou

CONTACT

+306987389354mz.nikolopoulou@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
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

April 14, 2025

First Posted

April 22, 2025

Study Start

April 22, 2025

Primary Completion

September 15, 2025

Study Completion

September 15, 2025

Last Updated

June 27, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)