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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-20

Study Completion Date

2025-09-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Airway Management Assessment Supraglottic Airways Supraglottic Airways for General Anesthesia Laryngeal Mask Airways

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Standard head position + i-gel

Group Type ACTIVE_COMPARATOR

STANDART HEAD POSITION

Intervention Type OTHER

STANDART HEAD POSITION

i-gel supraglottic airway device

Intervention Type DEVICE

i-gel supraglottic airway device

Rotated head position + i-gel

Group Type ACTIVE_COMPARATOR

HEAD ROTATION POSITION

Intervention Type OTHER

HEAD ROTATION POSITION

i-gel supraglottic airway device

Intervention Type DEVICE

i-gel supraglottic airway device

Standard head position + classic LMA

Group Type ACTIVE_COMPARATOR

STANDART HEAD POSITION

Intervention Type OTHER

STANDART HEAD POSITION

Classic laryngeal mask airway (LMA)

Intervention Type DEVICE

Classic laryngeal mask airway (LMA)

Rotated head position + classic LMA

Group Type ACTIVE_COMPARATOR

HEAD ROTATION POSITION

Intervention Type OTHER

HEAD ROTATION POSITION

Classic laryngeal mask airway (LMA)

Intervention Type DEVICE

Classic laryngeal mask airway (LMA)

Interventions

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STANDART HEAD POSITION

Intervention Type OTHER

HEAD ROTATION POSITION

Intervention Type OTHER

Classic laryngeal mask airway (LMA)

Intervention Type DEVICE

i-gel supraglottic airway device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No