Airway ManagementNCT06938308
Comparison Between the I-gel and Protector Supraglottic Airway Devices
A study testing LMA Igel and LMA Protector in people with Airway Management and Learning Curve, run by Nikolopoulou Maria Zozefin at 1 site in Greece.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Management, Learning Curve
- What is being tested?
- LMA Igel and LMA Protector
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- 22 Apr 2025to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I-II
- Patients older than 18 years
- Procedures in supine and lithotomy position
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
SismanoglioGH
Athens, Attica, 15126
Maria Kokolaki, +302132058001, dnths-anaisth@sismanoglio.gr
About this study
Official title: Comparison Between the I-gel and Protector Supraglottic Airway Devices in Patients Under General Anesthesia
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
- Conditions
- Airway Management, Learning Curve
- Being tested
- LMA Igel, LMA Protector
- Keywords
- I-gel, Protector, learning curve, LMA, airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA IgelDevice
adults allocated to the LMA Igel group, an LMA Igel device will be inserted intraoperatively
LMA ProtectorDevice
adults allocated to the LMA Protector group, an LMA Protector device will be inserted intraoperatively
| Study group | Role | What they receive |
|---|---|---|
| LMA Igel group | Active comparator | Not described Receives: Device: LMA Igel |
| LMA Protector group | Active comparator | Not described Receives: Device: LMA Protector |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time required for successful placement of the device
Measured: 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
Measured: During the placement attempt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start22 Apr 2025
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nikolopoulou Maria Zozefin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nikolopoulou Maria Zozefin, Sismanoglio General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938308
- Sponsor's protocol ID
- 9254/10-04-2025
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the I-gel and Protector Supraglottic Airway Devices in Patients Under General Anesthesia
- ClinicalTrials.gov ID
- NCT06938308
- Acronym / sponsor ID
- 9254/10-04-2025
- Conditions
- Airway Management, Learning Curve
- Keywords
- I-gel, Protector, learning curve, LMA, airway
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nikolopoulou Maria ZozefinUniversity, hospital or other
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMA Igel group | Active comparator | Device: LMA Igel |
| LMA Protector group | Active comparator | Device: LMA Protector |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-II
- Patients older than 18 years
- Procedures in supine and lithotomy position
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LMA Igeladults allocated to the LMA Igel group, an LMA Igel device will be inserted intraoperatively | Device | LMA Igel group |
| LMA Protectoradults allocated to the LMA Protector group, an LMA Protector device will be inserted intraoperatively | Device | LMA Protector group |
Primary outcome
The time required for successful placement of the device
Time frame: 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
1 secondary outcome
Documentation of adverse events during placement
Time frame: During the placement attempt
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LMA Igel and LMA Protector in people with Airway Management and Learning Curve, run by Nikolopoulou Maria Zozefin at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Zozefin Nikolopoulou (+306987389354, mz.nikolopoulou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time required for successful placement of the device (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.