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Recruiting NCT07027293

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

No phase Interventional Airway Management Assessment Supraglottic Airways Supraglottic Airways for General Anesthesia Laryngeal Mask Airways

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: STANDART HEAD POSITION, HEAD ROTATION POSITION, Classic laryngeal mask airway (LMA), i-gel supraglottic airway device.
Who it may be relevant to
Registry conditions: Airway Management Assessment, Supraglottic Airways, Supraglottic Airways for General Anesthesia, Laryngeal Mask Airways. Basic parameters: from 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other STANDART HEAD POSITION
    STANDART HEAD POSITION
  • Other HEAD ROTATION POSITION
    HEAD ROTATION POSITION
  • Device Classic laryngeal mask airway (LMA)
    Classic laryngeal mask airway (LMA)
  • Device i-gel supraglottic airway device
    i-gel supraglottic airway device

Primary outcome measures

  • Insertion Time of Supraglottic Airway Device [Time frame: 1-10 minutes]
  • Number of attempts for LMA replacement [Time frame: 15-200 seconds]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

Turkey (Türkiye) · 1 center
  • Yadigar Yılmaz — Istanbul

Identifiers

NCT: NCT07027293 · E-10840098-202.3.02-1265

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗