Impact of Preoxygenation Time on End-tidal Oxygen Concentration and on Hypoxic Events Occurring After Intubation in the Intensive Care Unit.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- Percentage of patients who reach an EtO2 of 90%
研究概览
简要总结
Preoxygenation is recommended before performing tracheal intubation. In intensive care units (ICU) patients, there is no specific recommendation regarding the duration of preoxygenation, which usually is applied for 3 to 5 minutes. Monitoring the effectiveness of preoxygenation with end-tidal oxygen concentration (EtO2) is strongly recommended in the operating room but it is never used in ICUs. The first aim of this pilot study is to assess the effect of the preoxygenation duration on EtO2, and secondarily, as an exploratory objective, to determine whether targeting a given value of EtO2 during preoxygenation might insure a safer intubation than when targeting pulse oximetry (SpO2).
详细描述
This is a multicenter randomized controlled pilot study. 110 patients who require intubation in the ICU will be randomly assigned, with a 1:1 ratio, to 3 or 5 minutes of preoxygenation duration. EtO2 will be continuously measured but hidden to the clinician. The primary outcome measure will be the obtention of an optimal preoxygenation defined by an EtO2 >90%. Secondary outcomes include the occurrence of hypoxia and complications during the procedure.
A pulse oximetry (SpO2) greater than or equal to 96% (SpO2 ≥ 96%) at the end of preoxygenation will be the target in each group. If at the end of the preoxygenation, SpO2 is still lower than 96%, clinician will be allowed to extend the duration of preoxygenation (up to 5 minutes in the 3 minutes period of preoxygenation group and up to 8 minutes in the 5 minutes period of preoxygenation group).
End-tidal oxygen concentration (EtO2) will be measured during preoxygenation and will be hidden to the clinician in order to not influence the duration of preoxygenation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years
- •Requiring intubation in ICU
- •Free express oral and informed consent of the patient or a proxy in case of impossibility for the patient to consent; emergency inclusion possible when legal representatives and patient's family are not present
排除标准
- •Intubation for cardiac arrest
- •End-tidal oxygen concentration monitoring not available
- •Preoxygenation with high-flow nasal oxygenation
- •Previous participation to the study
- •Patient known, at time of inclusion, as being under guardianship, tutorship or curator
- •Pregnancy or breastfeeding
- •Lack of social security number
结局指标
主要结局
Percentage of patients who reach an EtO2 of 90%
时间窗: 3 minutes
To compare the percentage of patients who reach an EtO2 of 90% or higher (optimal preoxygenation) at the end of the preoxygenation period between patients randomized in the 3-min and those randomized in the 5-min preoxygenation duration group.
次要结局
- Incidence of severe hypoxemia(End of preoxygenation)
- Incidence of severe complications(30 minutes after intubation)
- Partial Pressure of Oxygen (PaO2)(0 minute)
- Partial Pressure of Oxygen(at the 4th minute on average (3rd or 5th minute depending on the randomisation group))
- Expired oxygen fraction (FeO2)(Through preoxygenantion, i.e., an average of 4 minutes (a minimum of 3 and a maximum of 8 minutes))
- Lowest Pulsed saturation with Oxygen (SpO2)(30 minutes after the end of preoxygenation)
- Incidence of hypoxemia(5 minutes after intubation)