Feasibility of End-tidal Oxygen Concentration Monitoring During Preoxygenation for Intubation in the Intensive Care Unit. First Part, Preliminary Study of the IMPROVE Global Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of expired O2 at facemask during preoxygenation
研究概览
简要总结
Intubation is a common procedure in the intensive care unit. Hypoxemia is the most frequent complication of this procedure.
Monitoring the end-tidal of oxygen is recommended in operating room (OR). End-tidal of oxygen (EtO2) >90% is an indication of a correct preoxygenation.
This monitoring is not used in routine in intensive care unit (ICU). There is no recommendation on the monitoring of end-tidal of oxygen in intensive care unit. In practice, clinicians use pulsed oxygen saturation (SpO2) to determine whether the patient is sufficiently preoxygenated. However, this parameter is not a good indicator of a correct preoxygenation.
In the OR, patients are compliant during the preoxygenation period and the measure of EtO2 with the face mask monitor is considered reliable because i) mask leakage is minimal and ii) the patient can breathe slowly and regularly.
Theses conditions are not available in critical ill patients requiring emergency intubation. EtO2 measured on the facemask may not reflect true EtO2.
This concern about the reliability of EtO2 measurement via the facemask justifies that we conduct a study to compare EtO2 measured on a facemask (facemask EtO2) to EtO2 measured in pharynx (via e nasopharyngeal catheter).
The aim of this study is to determine whether the measurement of EtO2 on facemask is reliable in patients in ICU.
详细描述
This is a prospective non-comparative interventional study.
A double monitoring of EtO2 will be performed during the procedure of intubation (from the beginning of the preoxygenation to the success of intubation):
- In the pharynx (via a nasopharyngeal catheter) for the needs of the study
- On the facemask (as the practice in the OR) The duration of the study will not exceed one hour, including the installation of the devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
The clinician and caregivers in charge of the patient during the intubation procedure will be blinded: the facemask EtO2 and pharyngeal EtO2 will not be visible on the monitor for them
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
- •Age ≥ 18 years
- •Requiring an intubation in ICU for acute respiratory failure defined as a respiratory rate ≥ 25/min or clinical signs of respiratory distress or hypoxemia defined as oxygen requirement ≥ 15L/min or FiO2 ≥80% to maintain SpO2 ≥92% or a PaO2/FiO2 ratio <100 mmHg
- •With preoxygenation by noninvasive ventilation
排除标准
- •Intubation for cardiac arrest
- •EtO2 monitoring not available
- •Pulsed oxygen saturation monitoring specific for the study not available
- •Preoxygenation by high-flow nasal oxygen therapy or bag-mask ventilation
- •Allergy to lidocaine (for local nasal anesthesia)
- •Previously
- •Patient not affiliated or excluded from social protection, or under law protection (namely minors, pregnant or breastfeeding women, persons deprived of their liberty by court or administrative decision)
- •Previously included in the study
研究组 & 干预措施
monitoring of the expired oxygen fraction
A double monitoring of EtO2 will be performed during the procedure of intubation (from the beginning of the preoxygenation to the success of intubation):
- In the pharynx (via a nasopharyngeal catheter) for the needs of the study
- On the facemask (as the practice in the OR)
干预措施: double monitoring of EtO2 (Other)
结局指标
主要结局
Percentage of expired O2 at facemask during preoxygenation
时间窗: Hour 1
compare facemask EtO2 to pharyngeal EtO2 during preoxygenation in order to know if facemask monitoring is sufficient or if a nasopharyngeal catheter is absolutely necessary to monitor alveolar oxygenation.
Percentage of expired pharyngeal O2 during preoxygenation
时间窗: Hour 1
compare facemask EtO2 to pharyngeal EtO2 during preoxygenation in order to know if facemask monitoring is sufficient or if a nasopharyngeal catheter is absolutely necessary to monitor alveolar oxygenation.
次要结局
- Number of patient who had a pulsed oxygen saturation under 90%(Hour 1)