Comparing i-gel and classic LMA insertion in different head positions for people over 75
Evaluation of the Insertion of I-gel and Classic LMA in Different Head Positions in Elderly Patients
NA · Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · NCT07027293
This will test whether the i-gel or classic LMA is easier and faster to insert in different head positions for people over 75 having elective urological surgery under general anesthesia.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey (other) |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07027293 on ClinicalTrials.gov |
What this trial studies
This prospective, randomized, double-blind study will enroll 120 patients older than 75 years with ASA I-III and randomly assign them to four groups combining device (i-gel or classic LMA) and head position (standard or right lateral rotation). Clinicians will measure insertion time, ease and success of placement, number of attempts, hemodynamic responses, oropharyngeal leak pressures, fiberoptic view scores, and airway-related complications. The protocol compares performance of the two supraglottic devices across head positions to identify practical differences relevant to geriatric airway management. Results are intended to guide device selection and positioning for elderly patients undergoing general anesthesia.
Who should consider this trial
Good fit: Ideal candidates are people older than 75 with ASA physical status I-III scheduled for elective urological surgery who do not have a known or anticipated difficult airway and are eligible for a supraglottic airway.
Not a fit: Patients with known or expected difficult airways, contraindications to supraglottic devices, or those scheduled for endotracheal intubation are unlikely to benefit from the results.
Why it matters
Potential benefit: If successful, the study could identify the safer and more reliable device and head position to improve airway management and reduce complications in elderly surgical patients.
How similar studies have performed: Previous comparative studies often report faster insertion and higher leak pressures with i-gel versus classic LMA, but randomized data specifically in elderly patients across different head positions are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA classification I-III * Age over 75 years Exclusion Criteria: * Known or anticipated difficult airway * Contraindications for the use of a supraglottic airway device * Patients scheduled for endotracheal intubation
Where this trial is running
Istanbul
- Yadigar Yılmaz — Istanbul, Turkey (Türkiye) (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Airway Management Assessment, Supraglottic Airways, Supraglottic Airways for General Anesthesia, Laryngeal Mask Airways, Supraglottic airway device, i-gel, Classic laryngeal mask airway, Elderly patients