Comparison Between the I-gel and Protector Supraglottic A... | NCT06938308

Studies
Comparison Between the I-gel and Protector Supraglottic Airway Devices

NCT06938308

Sponsor

Nikolopoulou Maria Zozefin

Status

Recruiting

Last Update Posted

Jun 27, 2025Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Airway Management
Learning Curve

Interventions

LMA Igel
LMA Protector

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 22, 2025Actual

Primary Completion Date

Sep 15, 2025Estimated

Completion Date

Sep 15, 2025Estimated

First Submitted Date

Apr 14, 2025

First Submission Date that Met QC Criteria

Apr 14, 2025

First Posted Date

Apr 22, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2025

Last Update Posted Date

Jun 27, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nikolopoulou Maria Zozefin, Anesthesiology Resident at Sismanoglio General Hospital, Sismanoglio General HospitalSponsor-Investigator

Lead Sponsor

Nikolopoulou Maria ZozefinOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LMA Igel group	Active Comparator		Device: LMA Igel
LMA Protector group	Active Comparator		Device: LMA Protector

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LMA Igel	Device	adults allocated to the LMA Igel group, an LMA Igel device will be inserted intraoperatively	LMA Igel group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maria Zozefin Nikolopoulou	Contact	+306987389354		mz.nikolopoulou@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SismanoglioGH	Recruiting	Athens	Attica	15126	Greece

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided