The Insertion of I-gel and Classic LMA in Different Head Positions in Elderly Patients

September 10, 2025 updated by: Yadigar Yılmaz, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard head position + i-gel
Other: STANDART HEAD POSITION
STANDART HEAD POSITION
Device: i-gel supraglottic airway device
i-gel supraglottic airway device
Active Comparator: Rotated head position + i-gel
Device: i-gel supraglottic airway device
i-gel supraglottic airway device
Other: HEAD ROTATION POSITION
HEAD ROTATION POSITION
Active Comparator: Standard head position + classic LMA
Other: STANDART HEAD POSITION
STANDART HEAD POSITION
Device: Classic laryngeal mask airway (LMA)
Classic laryngeal mask airway (LMA)
Active Comparator: Rotated head position + classic LMA
Other: HEAD ROTATION POSITION
HEAD ROTATION POSITION
Device: Classic laryngeal mask airway (LMA)
Classic laryngeal mask airway (LMA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Insertion Time of Supraglottic Airway Device
Time Frame: 1-10 minutes
1-10 minutes
Number of attempts for LMA replacement
Time Frame: 15-200 seconds
15-200 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2025

Primary Completion (Estimated)

September 15, 2025

Study Completion (Estimated)

September 15, 2025

Study Registration Dates

First Submitted

May 27, 2025

First Submitted That Met QC Criteria

June 10, 2025

First Posted (Actual)

June 18, 2025

Study Record Updates

Last Update Posted (Estimated)

September 17, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E-10840098-202.3.02-1265

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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