Evaluation of the Insertion of I-gel and Classic LMA in Different Head Positions in Elderly Patients
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
干预措施: STANDART HEAD POSITION (Other)
Standard head position + i-gel
干预措施: i-gel supraglottic airway device (Device)
Rotated head position + i-gel
干预措施: HEAD ROTATION POSITION (Other)
Rotated head position + i-gel
干预措施: i-gel supraglottic airway device (Device)
Standard head position + classic LMA
干预措施: STANDART HEAD POSITION (Other)
Standard head position + classic LMA
干预措施: Classic laryngeal mask airway (LMA) (Device)
Rotated head position + classic LMA
干预措施: HEAD ROTATION POSITION (Other)
Rotated head position + classic LMA
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
Yadigar Yılmaz
MD
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
