NCT06616740已完成不适用
Comparison of the Effects of Paratracheal Compression and Cricoid Compression on LMA ProSeal Placement: a Randomised Clinical Trial.
Karaman Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年10月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Duration of insertion
研究概览
简要总结
The aim of this study is to compare the effect of paratracheal and cricoid pressure on LMA ProSeal insertion, insertion time, insertion difficulty, and the rate of optimal positioning of the device after insertion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
patients, care providers, investigator and outcome assessors will be blinded.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 19-70 years who are scheduled for general anaesthesia for whom LMA management would be appropriate.
排除标准
- •with cervical spine disease
- •expected difficult airway
- •upper airway abnormalities
- •body mass index (BMI) more than 35 kg/m2
- •high risk of aspiration (hiatus hernia, gastro-oesophageal reflux disease and starvation)
- •postoperative ventilator care
- •surgeries requiring positions other than supine.
结局指标
主要结局
Duration of insertion
时间窗: During intubation procedure
The time required for placement will be defined as the time from receipt of the LMA ProSeal to detection of the square waveform on capnography and will be calculated by summing the time taken for each attempt.
次要结局
- Sensation of resistance during inserting of LMA ProSeal(During intubation procedure)
- Anatomical location of the LMA ProSeal in the larynx and accuracy of insertion site.(1 minutes after intubation)
- Tidal volume and peak inspiratory pressure with or without each maneuver after LMA ProSeal insertion.(2 minutes after intubation)
- Oropharyngeal leak pressure(5 minutes after induction of general anesthesia)
研究者
muhammet korkusuz
Principal Investigator, MD
Karaman Training and Research Hospital
研究点 (2)
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