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

S

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Status

Not yet enrolling

Conditions

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

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07027293
E-10840098-202.3.02-1265

Details and patient eligibility

About

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 70 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.

Enrollment

120 estimated patients

Sex

All

Ages

70 to 95 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ASA classification I-III
  • Age over 70 years

Exclusion criteria

  • Known or anticipated difficult airway
  • Contraindications for the use of a supraglottic airway device
  • Patients scheduled for endotracheal intubation

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

120 participants in 4 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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