Comparison of Two FiO2 (1 or 0.5) for Tracheal Extubation in Post-anesthesia Care Unit : a Monocentric Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Decrease of oxygen saturation
研究概览
简要总结
The purpose of the study is to assess the optimal fraction of inspired oxygen (0.5 or 1) for extubation or removal of a supraglottic airway device after general anesthesia.
详细描述
During pre-anesthesia visit, eligible patients receive oral and written information of the study and potential risks.
In the operating room all patients giving a written informed consent will undergo at the end of surgery a screening to determine eligibility for study entry.
Before emergence from general anesthesia, patients who meet the eligibility requirements will be randomized in a open label manner to receive a 0.5 or 1 FiO2.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Patients undergoing general anesthesia, with invasive mechanical ventilation including an airway device (supraglottic airway device or tracheal tube) at their arrival in PACU.
- •ASA physical status classification 1, 2, or 3 stabilized.
- •Surgery performed in emergency operating room department including vascular, digestive, urological and minor trauma surgery or surgery performed in head and neck anesthesia pole block including anterior cervical spine, lumbar disc herniation, cranioplasty, nerve stimulator, vertebroplasty, narrow lumbar canal, simple arthrodesis (less than or equal to two stages), otological, ophthalmological and skin surgery.
排除标准
- •Per-operative hemodynamic instability.
- •Patients with a BMI greater than
- •Patients classified as difficult to intubate and / or ventilate.
- •Heavy surgeries (operating time greater than 4 hours).
- •Patient requiring postoperative non invasive mechanical ventilation
- •Patients with diagnosed COPD
- •SPO2 in room air < 96% before the intervention.
- •Any patient under guardianship.
- •Pre-operative and / or intra-operative morphine intake.
- •Surgical management of the upper airways (ex : tonsillectomy)
- •Pregnant and lactating women.
结局指标
主要结局
Decrease of oxygen saturation
时间窗: Duration of stay in post-anesthesia care unit, approximately one hour
Proportions of patients that present a decrease of 4 points of peripheral capillary oxygen saturation (SpO2) measured with pulse oximetry after extubation compared to their baseline room air SpO2
次要结局
- PACU length of stay(One hour)
- Duration of emergence(Up to one hour)
- Majored decrease of oxygen saturation(One hour)
- Primary Outcome Timing(Up to one hour)
- Number of risk factors(One hour)
- Corrective measures(One hour)