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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorSultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA classification I-III

Age over 75 years

Disqualifiers

Known or anticipated difficult airway

Contraindications for the use of a supraglottic airway device

Patients scheduled for endotracheal intubation

Trial design

Design model

Parallel

Treatments tested in this trial

  • STANDART HEAD POSITION

    Other intervention

    STANDART HEAD POSITION

  • HEAD ROTATION POSITION

    Other intervention

    HEAD ROTATION POSITION

  • Classic laryngeal mask airway (LMA)

    Device

    Classic laryngeal mask airway (LMA)

  • i-gel supraglottic airway device

    Device

    i-gel supraglottic airway device

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Standard head position + i-gelActive comparator 2 interventions
Group B: Rotated head position + i-gelActive comparator 2 interventions
Group C: Standard head position + classic LMAActive comparator 2 interventions
Group D: Rotated head position + classic LMAActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Insertion Time of Supraglottic Airway Device

Time frame
1-10 minutes
2

Number of attempts for LMA replacement

Time frame
15-200 seconds

Secondary outcomes

Other outcomes

Sponsors and contacts

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