Application of HFNC for the Prevention of Hypoxemia During Perioperative Anesthetic-induced Intubation in Children: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Apnoea time
研究概览
简要总结
Compared with adults, children have higher metabolic needs, and the airway is more likely to collapse. Before tracheal intubation after anesthesia induction, the patient 's spontaneous breathing completely disappears. At this critical stage, the residual oxygen of the lung is consumed, resulting in hypoxemia and atelectasis. Therefore, it is necessary to explore the best oxygenation strategy during intubation. In addition, ultrasound has become a common equipment in the operating room. It has the advantages of portability, repeatability, and no radiation, and can provide strong support for the diagnosis of gastric distension.
详细描述
At present, hypoxia is still the main cause of complications and death during perioperative period. Compared with adults, children have lower functional residual volume and lower tolerance to hypoxia caused by apnea due to their special physiological and functional characteristics. During anesthesia induction and tracheal intubation, spontaneous breathing completely disappears. At this critical stage, hypoxemia is prone to occur, which in turn causes various serious complications. Mask ventilation may occur mask ventilation difficulties and flatulence ; since the introduction of nasal high-flow oxygen therapy ( HFNC ) into the operating room in 2015, its oxygenation method has been shown to be able to significantly improve blood oxygen when used alone in pre-oxygenation. When tracheal intubation is performed, HFNC can still maintain ventilation in the patient 's nose, so HFNC can combine the advantages of both masks to perform pre-oxygenation. There are few studies on the effect of HFNC on apnea oxygenation in children in the operating room.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 2-10 years old;
- •American Society of Anesthesiologists (ASA) Level I or II;
- •Children with healthy lungs and hearts;
- •Clear headed and able to cooperate with anesthesiologists for treatment.
排除标准
- •Contraindications for HFNC: (1) Complete obstruction of the upper respiratory tract; (2) Skull base fracture or nasal bone fracture; (3) Patients who refuse to use HFNC;
- •The American Society of Anesthesiologists (ASA) rating is greater than Level II;
- •Children with upper respiratory tract infections within 2 weeks;
- •Pulmonary dysfunction, congenital heart disease in children;
研究组 & 干预措施
Group HFNC
In the HFNC group, the mask ventilation was performed after the patient lost spontaneous breathing until the end-tidal oxygen concentration reached 90 %. The mask was removed and HFNC ( AIRVO2, Fisher Parker Medical Company, Auckland, New Zealand ) was used to record the patient 's safe apnea time. After the end of positive pressure ventilation, intubation or laryngeal mask placement was performed after the end-tidal oxygen concentration reached 90 % or more. During the intubation or placement of the laryngeal mask, the HFNC nasal catheter was kept in the patient 's nose for apnea oxygenation.
干预措施: high-flow nasal cannula (Device)
Group control
No intervention
结局指标
主要结局
Apnoea time
时间窗: 2-10min
Investigators will record the time of oxygen saturation drop to 95 % during intubation.
次要结局
未报告次要终点