The Effects of Setting Adjustable Pressure Limiting Valve (APL) to 5 cmH2O on Preoxygenation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- time to reach end expiratory fraction of oxygen of 90% or more
研究概览
简要总结
The aim of this study is to investigate the effects of setting airway pressure release valve (APL valve) on the anesthesia workstation to 5 cmH2O during spontaneous breathing on preoxygenation. In this prospective study healthy volunteers are randomized in cross-over between spontaneous breathing with the APL valve on spontaneous position or spontaneous breathing with the APL valve on 5 cmH2O or CPAP (continous positive airway pressure) mode with 5 cmH2O PEEP (positive end expiratory pressure).
详细描述
There are several methods to improve preoxygenation but most of them require advanced anesthesia workstations. Therefore the investigators planned an an experimental study on healthy volunteers to investigate the effects of a simple method on preoxygenation.
Healthy volunteers are randomized in cross-over between spontaneous breathing with the APL valve on spontaneous position or spontaneous breathing with the APL valve on 5 cmH2O or CPAP mode with 5 cmH2O PEEP.
The volunteers will breath through an anesthesia face mask. The fresh gas flow rate is 12 L/min, inspiratory fraction of oxygen is 100%. The exhaled gas (oxygen and carbon dioxide) are monitored. The inspiratory and end expiratory fraction of oxygen will be recorded every 10 seconds.
The primary endpoint is the time to achieve end expiratory fraction of oxygen of 90% or more.The secondary endpoint is the proportion of subject with end expiratory fraction of oxygen of 90% or more after a 3 min period and the end expiratory fraction of oxygen at the third minute.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers
排除标准
- •any respiratory disease
研究组 & 干预措施
spontaneous breathing
volunteers will breath via an anesthesia face mask spontaneously while the APL (airway pressure release valve) valve is on the spontaneous position.
干预措施: preoxygenation with 100% O2, fresh gas flow rate 12 L/minute (Procedure)
spontaneous breathing with APL 5 cmH2O
volunteers will breath via an anesthesia face mask spontaneously while the APL (airway pressure release valve) valve is on the 5 cmH2O position.
干预措施: preoxygenation with 100% O2, fresh gas flow rate 12 L/minute (Procedure)
CPAP 5cmH2O PEEP
volunteers will breath via an anesthesia face mask spontaneously on the CPAP mode of the anesthesia workstation with 5 cmH2O PEEP.
干预措施: preoxygenation with 100% O2, fresh gas flow rate 12 L/minute (Procedure)
结局指标
主要结局
time to reach end expiratory fraction of oxygen of 90% or more
时间窗: 5 minutes
次要结局
- Verbal rating Score(5 minutes)
- proportion of volunteer with end expiratory fraction of oxygen of 90% or more after a 3 min period(3 minutes)
- End expiratory oxygen fraction at the 3th minute(3 minutes)
研究者
MAHMUT ARSLAN
Assistant Professor
Kahramanmaras Sutcu Imam University