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临床试验/NCT07027293
NCT07027293招募中不适用

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

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年6月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Insertion Time of Supraglottic Airway Device

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •ASA classification I-III
  • •Age over 75 years

排除标准

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

研究组 & 干预措施

Standard head position + i-gel

Active Comparator

干预措施: STANDART HEAD POSITION (Other)

Standard head position + i-gel

Active Comparator

干预措施: i-gel supraglottic airway device (Device)

Rotated head position + i-gel

Active Comparator

干预措施: HEAD ROTATION POSITION (Other)

Rotated head position + i-gel

Active Comparator

干预措施: i-gel supraglottic airway device (Device)

Standard head position + classic LMA

Active Comparator

干预措施: STANDART HEAD POSITION (Other)

Standard head position + classic LMA

Active Comparator

干预措施: Classic laryngeal mask airway (LMA) (Device)

Rotated head position + classic LMA

Active Comparator

干预措施: HEAD ROTATION POSITION (Other)

Rotated head position + classic LMA

Active Comparator

干预措施: Classic laryngeal mask airway (LMA) (Device)

结局指标

主要结局

Insertion Time of Supraglottic Airway Device

时间窗: 1-10 minutes

Number of attempts for LMA replacement

时间窗: 15-200 seconds

次要结局

未报告次要终点

研究者

发起方
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yadigar Yılmaz

MD

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

研究点 (1)

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