NCT07027293

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

June 20, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

May 27, 2025

Last Update Submit

September 10, 2025

Conditions

Airway Management AssessmentSupraglottic AirwaysSupraglottic Airways for General AnesthesiaLaryngeal Mask Airways

Keywords

Supraglottic airway devicei-gelClassic laryngeal mask airwayElderly patientsAirway managementHead positionGeneral anesthesiaInsertion success

Outcome Measures

Primary Outcomes (2)

  • Insertion Time of Supraglottic Airway Device

    1-10 minutes

  • Number of attempts for LMA replacement

    15-200 seconds

Study Arms (4)

Standard head position + i-gel

ACTIVE COMPARATOR
Other: STANDART HEAD POSITIONDevice: i-gel supraglottic airway device

Rotated head position + i-gel

ACTIVE COMPARATOR
Other: HEAD ROTATION POSITIONDevice: i-gel supraglottic airway device

Standard head position + classic LMA

ACTIVE COMPARATOR
Other: STANDART HEAD POSITIONDevice: Classic laryngeal mask airway (LMA)

Rotated head position + classic LMA

ACTIVE COMPARATOR
Other: HEAD ROTATION POSITIONDevice: Classic laryngeal mask airway (LMA)

Interventions

STANDART HEAD POSITIONOTHER

STANDART HEAD POSITION

Standard head position + classic LMAStandard head position + i-gel
HEAD ROTATION POSITIONOTHER

HEAD ROTATION POSITION

Rotated head position + classic LMARotated head position + i-gel
Classic laryngeal mask airway (LMA)DEVICE

Classic laryngeal mask airway (LMA)

Rotated head position + classic LMAStandard head position + classic LMA
i-gel supraglottic airway deviceDEVICE

i-gel supraglottic airway device

Rotated head position + i-gelStandard head position + i-gel

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • ASA classification I-III
  • Age over 75 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yadigar Yılmaz

Istanbul, 34230, Turkey (Türkiye)

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 27, 2025

First Posted

June 18, 2025

Study Start

June 20, 2025

Primary Completion

September 15, 2025

Study Completion

September 15, 2025

Last Updated

September 17, 2025

Record last verified: 2025-09

Locations

TU(1)