跳至主要内容
临床试验/NCT06938308
NCT06938308招募中不适用

Comparison Between the I-gel and Protector Supraglottic Airway Devices in Patients Under General Anesthesia

Nikolopoulou Maria Zozefin1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年4月22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
200
试验地点
1
主要终点
The time required for successful placement of the device

研究概览

简要总结

This study aims to compare the learning curves of two different laryngeal mask airway devices, by evaluating their placement in adult patients performed by anesthesiology residents

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
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients older than 18 years
  • •Procedures in supine and lithotomy position

排除标准

  • •Tumors or anatomical anomalies of the upper airway
  • •Known history of difficult intubation
  • •Limited mouth opening less than 2cm
  • •Decreased compliance of the lungs or the thoracic cage
  • •Need of mechanical ventilation after the surgery

研究组 & 干预措施

LMA Igel group

Active Comparator

干预措施: LMA Igel (Device)

LMA Protector group

Active Comparator

干预措施: LMA Protector (Device)

结局指标

主要结局

The time required for successful placement of the device

时间窗: Measured from the moment the clinician picks up the LMA device after induction of general anesthesia until the appearance of the first capnography waveform on the monitor with a maximum duration of 60 seconds per attempt and up to three attempts allowed

次要结局

  • Documentation of adverse events during placement(During the placement attempt)

研究者

发起方
Nikolopoulou Maria Zozefin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nikolopoulou Maria Zozefin

Anesthesiology Resident at Sismanoglio General Hospital

Sismanoglio General Hospital

研究点 (1)

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