Safe Time for Apnea After Preoxygenation With Different Oxygen Concentration During the Induction of General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Safe time for apnea
研究概览
简要总结
The use of 100% oxygen during the induction of general anesthesia is always preferable to have enough time to secure the airway by endotracheal intubation, because preoxygenation with a low oxygen concentration may reduce the safe time for apnea. However, using a low oxygen concentration during preoxygenation might prevent the formation of atelectasis. There is still no clear conclusion about the best oxygen concentration for preoxygenation. Our study is designed to evaluate the safety of preoxygenation with 80%, 60%, 40%, 30% and 21% oxygen by the safe time for apnea during the induction of general anesthesia.
详细描述
We decide to add 3 groups (80%, 60%, and 40% oxygen) in our study to fully evaluate the safety of preoxygenation with different oxygen concentration.
Zijia Li 2018.3.2
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nonsmoking patients aged 18 years to 60 years
- •Undergoing general anesthesia for elective surgery
- •Pulse oxygen saturation ≥95% when breathing air quietly in bed
- •American Society of Anesthesiologists(ASA) physical status class I-II
- •Informed consent can be obtained
排除标准
- •A suspected difficult airway
- •Be allergic to midazolam, propofol , fentanyl or Cisatracurium
- •Severe disease of respiratory system or cardiovascular system,or obstruction of the digestive tract
- •Oxygen reserve is suspected low,or patient who does not tolerate hypoxemia well
- •A history of mental disorder or patient who can not collaborate well
- •Body mass index more than 30 kg/㎡
研究组 & 干预措施
group F
80% Oxygen
干预措施: 80% Oxygen (Drug)
group A
100% Oxygen
干预措施: 100% Oxygen (Drug)
group B
30% Oxygen.
干预措施: 30% Oxygen (Drug)
group C
21% Oxygen
干预措施: 21% Oxygen (Drug)
group D
40% Oxygen
干预措施: 40% Oxygen (Drug)
group E
60% Oxygen
干预措施: 60% Oxygen (Drug)
结局指标
主要结局
Safe time for apnea
时间窗: 10 min
Time when peripheral oxygen saturation (SpO2) is ≥ 90% after preoxygenation.
次要结局
- Time needed for endotracheal intubation(1 min)
研究者
Zijia Li
Principal Investigator, Department of anesthesiology, Sixth Affiliated Hospital, Sun Yat-sen University
Sixth Affiliated Hospital, Sun Yat-sen University