Airway Management AssessmentNCT07027293
The Insertion of I-gel and Classic LMA in Different Head Positions in Elderly Patients
A study testing STANDART HEAD POSITION, HEAD ROTATION POSITION and Classic laryngeal mask airway (LMA) in people with Airway Management Assessment and Supraglottic Airways, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, double-blind clinical study aims to evaluate the insertion success of two supraglottic airway devices, the classic Laryngeal Mask Airway (LMA) and the I-gel, in different head and neck positions in elderly patients undergoing elective urological surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Airway Management Assessment, Supraglottic Airways, Supraglottic Airways for General Anesthesia
- What is being tested?
- STANDART HEAD POSITION, HEAD ROTATION POSITION and Classic laryngeal mask airway (LMA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ASA classification I-III
- Age over 75 years
Who cannot join
- Known or anticipated difficult airway
- Contraindications for the use of a supraglottic airway device
- Patients scheduled for endotracheal intubation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yadigar Yılmaz
Istanbul, 34230
Yadigar Yılmaz, 5053069924, dryadigaryilmaz@gmail.com
About this study
Official title: Evaluation of the Insertion of I-gel and Classic LMA in Different Head Positions in Elderly Patients
This prospective, randomized, double-blind clinical study aims to evaluate the insertion success of two supraglottic airway devices, the classic Laryngeal Mask Airway (LMA) and the I-gel, in different head and neck positions in elderly patients undergoing elective urological surgery under general anesthesia. A total of 120 patients aged over 75 years with ASA physical status I-III will be randomly assigned to one of four groups: standard position with I-gel, right lateral rotation with I-gel, standard position with classic LMA, and right lateral rotation with classic LMA. The study will compare insertion time, ease and success of placement, number of attempts, hemodynamic responses, oropharyngeal leak pressures, fiberoptic scores, and airway-related complications. The findings aim to provide clinical guidance on the optimal use of supraglottic airway devices in geriatric patients in various head positions.
- Conditions
- Airway Management Assessment, Supraglottic Airways, Supraglottic Airways for General Anesthesia, Laryngeal Mask Airways
- Being tested
- STANDART HEAD POSITION, HEAD ROTATION POSITION, Classic laryngeal mask airway (LMA), i-gel supraglottic airway device
- Keywords
- Supraglottic airway device, i-gel, Classic laryngeal mask airway, Elderly patients, Airway management, Head position, General anesthesia, Insertion success
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STANDART HEAD POSITIONOther
STANDART HEAD POSITION
HEAD ROTATION POSITIONOther
HEAD ROTATION POSITION
Classic laryngeal mask airway (LMA)Device
Classic laryngeal mask airway (LMA)
i-gel supraglottic airway deviceDevice
i-gel supraglottic airway device
| Study group | Role | What they receive |
|---|---|---|
| Standard head position + i-gel | Active comparator | Not described Receives: Other: STANDART HEAD POSITION; Device: i-gel supraglottic airway device |
| Rotated head position + i-gel | Active comparator | Not described Receives: Other: HEAD ROTATION POSITION; Device: i-gel supraglottic airway device |
| Standard head position + classic LMA | Active comparator | Not described Receives: Other: STANDART HEAD POSITION; Device: Classic laryngeal mask airway (LMA) |
| Rotated head position + classic LMA | Active comparator | Not described Receives: Other: HEAD ROTATION POSITION; Device: Classic laryngeal mask airway (LMA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insertion Time of Supraglottic Airway Device
Measured: 1-10 minutes
Number of attempts for LMA replacement
Measured: 15-200 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start20 Jun 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 Management AssessmentStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yadigar Yılmaz, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027293
- Sponsor's protocol ID
- E-10840098-202.3.02-1265
- Status last verified
- Sep 2025
- First submitted
- 27 May 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Insertion of I-gel and Classic LMA in Different Head Positions in Elderly Patients
- ClinicalTrials.gov ID
- NCT07027293
- Acronym / sponsor ID
- E-10840098-202.3.02-1265
- Conditions
- Airway Management Assessment, Supraglottic Airways, Supraglottic Airways for General Anesthesia, Laryngeal Mask Airways
- Keywords
- Supraglottic airway device, i-gel, Classic laryngeal mask airway, Elderly patients, Airway management, Head position, General anesthesia, Insertion success
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 18 Jun 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 prospective, randomized, double-blind clinical study aims to evaluate the insertion success of two supraglottic airway devices, the classic Laryngeal Mask Airway (LMA) and the I-gel, in different head and neck positions in elderly patients undergoing elective urological surgery under general anesthesia. A total of 120 patients aged over 75 years with ASA physical status I-III will be randomly assigned to one of four groups: standard position with I-gel, right lateral rotation with I-gel, standard position with classic LMA, and right lateral rotation with classic LMA. The study will compare insertion time, ease and success of placement, number of attempts, hemodynamic responses, oropharyngeal leak pressures, fiberoptic scores, and airway-related complications. The findings aim to provide clinical guidance on the optimal use of supraglottic airway devices in geriatric patients in various head positions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard head position + i-gel | Active comparator | Other: STANDART HEAD POSITION, Device: i-gel supraglottic airway device |
| Rotated head position + i-gel | Active comparator | Other: HEAD ROTATION POSITION, Device: i-gel supraglottic airway device |
| Standard head position + classic LMA | Active comparator | Other: STANDART HEAD POSITION, Device: Classic laryngeal mask airway (LMA) |
| Rotated head position + classic LMA | Active comparator | Other: HEAD ROTATION POSITION, Device: Classic laryngeal mask airway (LMA) |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- ASA classification I-III
- Age over 75 years
Key exclusion criteria (3 listed)
- Known or anticipated difficult airway
- Contraindications for the use of a supraglottic airway device
- Patients scheduled for endotracheal intubation
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 |
|---|---|---|
| STANDART HEAD POSITIONSTANDART HEAD POSITION | Other | Standard head position + classic LMA, Standard head position + i-gel |
| HEAD ROTATION POSITIONHEAD ROTATION POSITION | Other | Rotated head position + classic LMA, Rotated head position + i-gel |
| Classic laryngeal mask airway (LMA)Classic laryngeal mask airway (LMA) | Device | Rotated head position + classic LMA, Standard head position + classic LMA |
| i-gel supraglottic airway devicei-gel supraglottic airway device | Device | Rotated head position + i-gel, Standard head position + i-gel |
Primary outcome
Insertion Time of Supraglottic Airway Device
Time frame: 1-10 minutes
Number of attempts for LMA replacement
Time frame: 15-200 seconds
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 17 Sep 2025.
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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 STANDART HEAD POSITION, HEAD ROTATION POSITION and Classic laryngeal mask airway (LMA) in people with Airway Management Assessment and Supraglottic Airways, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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 17 Sep 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 Turkey (Türkiye). 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insertion Time of Supraglottic Airway Device (time frame: 1-10 minutes). The study lists 2 primary outcomes in all. 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 17 Sep 2025.