Actively Recruiting
Evaluation of the Insertion of I-gel and Classic LMA in Different Head Positions in Elderly Patients
Led by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Updated on 2025-09-17
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the insertion success of two supraglottic airway devices, the classic Laryngeal Mask Airway (LMA) and the i-gel, in elderly patients over 75 years old undergoing elective urological surgery under general anesthesia. The study aims to compare these devices when used in different head and neck positions to provide guidance on the best airway management approach for older adults. The trial is a prospective, randomized, double-blind clinical study involving 120 patients with ASA physical status I-III. Participants will be randomly assigned to one of four groups: standard head position with i-gel, right lateral head rotation with i-gel, standard head position with classic LMA, or right lateral head rotation with classic LMA. The interventions include the use of the two airway devices in either a standard or rotated head position during surgery. The study will assess how easily and quickly the devices can be inserted in these positions. During the study, researchers will measure insertion time, number of attempts needed for placement, ease of insertion, hemodynamic responses, oropharyngeal leak pressures, fiberoptic scores, and any airway-related complications. These assessments will help determine which device and head position combination works best for airway management in elderly patients. The total duration of participation depends on the surgical procedure and anesthesia period.
CONDITIONS
Brief Title
The Insertion of I-gel and Classic LMA in Different Head Positions in Elderly Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ASA physical status classification I to III
- Age over 75 years
You will not qualify if you...
- Known or anticipated difficult airway
- Contraindications for the use of a supraglottic airway device
- Patients scheduled for endotracheal intubation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 10 minutes
Participants receive either the i-gel supraglottic airway device or the classic laryngeal mask airway in different head positions during the procedure.
1 procedure visit
Duration - 15 to 200 seconds
Participants are observed briefly after airway device insertion to monitor the number of attempts and ensure proper placement.
1 observation visit
Trial Site Locations
Total: 1 location
1
Yadigar Yılmaz
Istanbul, Turkey (Türkiye), 34230
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
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