Comparison of Preoxygenation Techniques in Healthy Volunteers With Monitoring of End-tidal Oxygen Fraction (FeO₂) and Oxygen Reserve Index (ORI).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in end-tidal oxygen fraction (FeO2) at the end of each preoxygenation technique
研究概览
简要总结
The objective of this physiological study is to compare two preoxygenation techniques (non-invasive ventilation combined with high-flow nasal oxygen versus non-invasive ventilation alone) by monitoring end-tidal oxygen fraction (FeO₂) and the Oxygen Reserve Index (ORI) during 3 minutes of preoxygenation in healthy volunteers.
详细描述
An intubation procedure is performed in several successive phases:
- Preoxygenation phase: This phase consists of administering 100% oxygen for 3 to 5 minutes in order to increase oxygen reserves.
- Alveolar hypoventilation phase: This phase begins with the administration of anesthetic agents, leading to a reduction in spontaneous ventilation.
- Apnea phase: During this phase, laryngoscopy is performed and the endotracheal tube is inserted into the trachea.
- Initiation of invasive mechanical ventilation: Once intubation is successful, the patient is placed on assisted mechanical ventilation.
Several devices can be used to perform preoxygenation:
- Bag-valve mask (BVM)
- High-flow nasal cannula therapy (HFNC)
- Non-invasive ventilation (NIV):
Current recommendations from critical care societies suggest the use of:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 是
入选标准
- •Male or female
- •Healthy volunteer who has provided written informed consent
- •Age > 18 years
排除标准
- •Long-term oxygen therapy
- •Cardiac or pulmonary disease (including asthma)
- •Presence of Raynaud's syndrome
- •Claustrophobia
- •Body mass index (BMI) ≥ 30 kg/m²
- •Presence of nail polish preventing accurate SpO₂ and ORI measurement
- •Under legal protection
- •Incarcerated individuals
- •Persons deprived of liberty
- •Not affiliated to French social security
- •Pregnant or breastfeeding women
- •Individuals currently participating in a drug study and still within the exclusion period
研究组 & 干预措施
Non-invasive ventilation combined to high flow nasal cannula
- NIV + HFNC: Non-invasive ventilation in pressure-controlled mode with inspiratory pressure adjusted to achieve a tidal volume of 6-8 mL/kg (in practice, inspiratory pressure between 5 and 10 cmH₂O) and a PEEP of 5 cmH₂O, combined with high-flow nasal cannula oxygen at 60 L/min with an FiO₂ of 100%
干预措施: Preoxygenation with VNI + OHD (Other)
Non invasive ventilation
- NIV alone in pressure-controlled mode with inspiratory pressure adjusted to achieve a tidal volume of 6-8 mL/kg (in practice, inspiratory pressure between 5 and 10 cmH₂O) and a PEEP of 5 cmH₂O
干预措施: Preoxygenation with VNI (Other)
结局指标
主要结局
Change in end-tidal oxygen fraction (FeO2) at the end of each preoxygenation technique
时间窗: 3 minutes
FeO2 will be collected every 12 seconds during preoxygenation. The mean FeO2 value at 3 minutes will be used for comparison between techniques.
次要结局
- Change in end-tidal oxygen fraction (FeO2) during each preoxygenation technique(3 minutes)
- Maximum FeO2 value(3 minutes)
- Average Oxygen Reserve Index (ORI) value(3 minutes)
- Maximum ORI value(3 minutes)
- Change in ORI during each preoxygenation technique(3 minutes)
- Change in peripheral oxygen saturation (SpO2) during each preoxygenation technique(3 minutes)
- Time (in seconds) required to reach an ORI value ≥ 0.60 and FeO2 ≥ 90% during the 3 minutes of each preoxygenation technique(3 minutes)
- Time (in seconds) for ORI to return to 0 after cessation of preoxygenation.(3 minutes)
- Change in ventilator parameters (inspiratory and expiratory tidal volumes)(3 minutes)