Airway ManagementNCT06825910
LMA I-Gel Versus LMA Protector During Minor Urological Procedures Under General Anesthesia in Adult Patients
A study testing LMA igel and LMA protector in people with Airway Management and General Anesthesia, run by Nikolopoulou Maria Zozefin at 2 sites in Greece.
Trial 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. 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, General Anesthesia
- 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
- 100 participants
- Where
- 2 sitesGreece
- Study dates
- 1 Feb 2025to 30 Dec 2026
- 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Greece2 sites, 2 recruiting
- Not yet recruiting
SismanoglioGH
Athens
Maria Kokolaki, +302132058001, dnths-anaisth@sismanoglio.gr
- Recruiting
SismanoglioGH
Athens
Maria Kokolaki, +302132058001, dnths-anaisth@sismanoglio.gr
About this study
Official title: 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.
Read the 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.
- Conditions
- Airway Management, General Anesthesia
- Being tested
- LMA igel, LMA protector
- Keywords
- LMA, Protector, Airway Device Evaluation, iGel, Airway Device Comparison
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.
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
Measured: 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 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
Measured: 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: 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
Measured: 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
Measured: Immediately after the exertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Feb 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 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
- NCT06825910
- Sponsor's protocol ID
- 19242/29.08.24
- Status last verified
- Apr 2026
- First submitted
- 12 Jan 2025
- Last updated
- 27 Apr 2026
- 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 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngeal Mask Airway I-Gel and Laryngeal Mask Airway Protector for Minor Urological Procedures Under General Anesthesia in Adult Patients: A Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT06825910
- Acronym / sponsor ID
- 19242/29.08.24
- Conditions
- Airway Management, General Anesthesia
- Keywords
- LMA, Protector, Airway Device Evaluation, iGel, Airway Device Comparison
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nikolopoulou Maria ZozefinUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 13 Feb 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 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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- 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
Evaluation of the airway sealing pressure of the Laryngeal Mask Airway (LMA) in neutral, extended, and extended-rotated head positions
Time frame: 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
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
4 secondary outcomes
Success rate of each device for patients with a potential difficult airway according to the Simplified Airway Index
Time frame: 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
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
Number of attempts to successfully place a nasogastric tube through the specially designed channels of the laryngeal mask
Time frame: 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
Time frame: Immediately after the exertion
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 Apr 2026.
- 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.
2 sites 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 General Anesthesia, run by Nikolopoulou Maria Zozefin at 2 sites 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 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Evaluation of the airway sealing pressure of the Laryngeal Mask Airway (LMA) in neutral, extended, and extended-rotated head positions (time frame: 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). 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 Apr 2026.