Comparison of Preoxygenation With a High-flow Nasal Cannula and a Simple Mask Before Intubation During Induction of General Anesthesia in Patients Undergoing Head and Neck Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- PaO2 (arterial oxygen partial pressure) at pre-defined time points.
研究概览
简要总结
Objectives: To assess arterial oxygen partial pressure (PaO2) at defined time points during the preoxygenation and to compare between high flow heated humidified nasal oxygen versus standard preoxygenation with oxygen insufflation via face mask over at least 5 minutes Methods: This randomized, single-blinded, prospective study was conducted at Asan Medical Center in Seoul, Republic of Korea.
Populations: Patients undergoing head and neck surgery Expected outcomes: The course of PaO2 levels is superior to those of the face mask during the whole preoxygenation procedure and after the intubation.
详细描述
Rationale & background information:
Pre-oxygenation before general anesthesia is usually achieved using oxygen delivered via a facemask before induction of anesthesia; this potentially extends the time available for securing the airway before hypoxemia to 6 min. The lungs are commonly ventilated with a bag/facemask technique after induction, and this can be repeated if attempts at intubating the trachea are prolonged. However, facemask ventilation has traditionally been avoided in the circumstance which has the risk of gastric insufflation of gas, leading to increased intragastric pressure and raised risk of pulmonary aspiration of stomach contents. In addition, if difficult ventilation is anticipated, facemask ventilation may not be possible at all, and 6 minutes with hypoxemia may be insufficient for intubation.
An ideal preoxygenation to extend apnea tolerance during anesthesia induction is essential to avoid live threatening airway incidents. The high-flow nasal cannula, the OptiFlow System (Thrive, Fisher & Paykel®, Aukland New Zealand), has the ability to deliver warmed and humidified oxygen through specially designed nasal cannula and enable oxygen to be comfortably delivered at rates of > 70 liter/min. Several study showed that nasal delivery of humidified oxygen to paralyzed and anesthetized patients at these rates maintains oxygenation and achieves acceptable carbon dioxide concentration. The investigators hypothesized that an extended apneic period without facemask ventilation could be particularly beneficial to patients undergoing general anaesthesia.
Study goals and objectives:
To assess arterial oxygen partial pressure (PaO2) at defined time points during the preoxygenation and to compare between high flow heated humidified nasal oxygen versus standard preoxygenation with oxygen insufflation via face mask over at least 5 minutes
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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with head and neck cancer undergoing resection surgery planned arterial cannulation and invasive arterial blood pressure monitoring and arterial blood gas analysis
- •Patients over 19-year old
- •Patients who voluntarily participated in the study
- •Patents in American Society of Anesthesia physical status 1-3
排除标准
- •Patients who don't approve to participation
- •Unable to give informed consent because of a language barrier
- •Patients with severe respiratory disease
- •Patients with severe cardiovascular or cerebrovascular disease
- •Patients with severe psychiatric disorders
- •Anyone who is not appropriate according to researcher's decision
研究组 & 干预措施
Group N
pre-oxygenation with High-flow nasal cannula
干预措施: High-flow nasal cannula (Device)
Group M
pre-oxygenation with simple mask
干预措施: simple mask (Device)
结局指标
主要结局
PaO2 (arterial oxygen partial pressure) at pre-defined time points.
时间窗: through study completion, an average of 10 minutes
changes of PaO2
次要结局
- degree of blood oxygenation oxygenation(through study completion, an average of 10 minutes)
- degree of tissue oxygenation(through study completion, an average of 10 minutes)
- various patients' characteristics about airway(through study completion, an average of 10 minutes)
- degree of difficulty for intubation(through study completion, an average of 10 minutes)
研究者
Seong-Soo Choi, MD, PhD
Assistant professor
Asan Medical Center