NCT05989880招募中不适用
Pilot Feasibility Trial of the SafeLM Supraglottic Airway
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年9月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Intubation success rate
研究概览
简要总结
The purpose of this study is to assess the feasibility of SafeLM as a primary airway device and as a conduit for intubation with and without the use of a bougie
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective surgery requiring general anesthesia and airway management using a supraglottic airway device or endotracheal intubation
排除标准
- •pregnancy
- •known or suspected difficult airway management
- •history of oropharyngeal or upper airway surgery
- •known or suspected airway or respiratory pathology, such as significant obstructive sleep apnea or chronic obstructive pulmonary disease (COPD)
- •BMI greater than 40 kg/m2
- •unable to undergo intubation via the oral route
- •known or suspected full stomach or other risk factors for aspiration
- •contraindication for the use of neuromuscular blocking agents
- •history of significant gastroesophageal reflux disease (GERD)
- •Vulnerable populations (cognitively impaired persons, prisoners)
结局指标
主要结局
Intubation success rate
时间窗: at the time of intubation
This is assessed by the ability of the SafeLM to achieve adequate oxygenation and ventilation via the respective procedure once the airway device is in place.
次要结局
- Safety of the SafeLM as a conduit for intubation(at the time of intubation)
- Number of insertion attempts required to achieve effective oxygenation and ventilation(at the time of intubation)
- Subjective ease of insertion of the airway device(at the time of intubation)
- Safety of the SafeLM as an SGA(at the time of intubation)
- Time to insertion(at the time of intubation)
研究者
Lauren Nakazawa
Assistant Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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