Feasibility of Preoxygenation by Supraglottic Jet Ventilation Substituted for Mask Pressurized Ventilation Before Endotracheal Intubation:A Randomized Controlled Trail
试验速览
- 阶段
- 不适用
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- alveolar oxygen tension（PaO2）
研究概览
简要总结
The study assumed that supraglottic jet ventilation is an alternative solution as a safe way to do the preoxygenation before endotracheal intubation by contrasting it with mask pressurized ventilation. The investigators also expected that supraglottic jet ventilation won't increase the occurrence of esophageal reflux.
详细描述
The study assumed that supraglottic jet ventilation is an alternative solution as a safe way to do the preoxygenation before endotracheal intubation by contrasting it with mask pressurized ventilation. The investigators also expected that supraglottic jet ventilation won't increase the occurrence of esophageal reflux.
The investigators randomly divided the patients into 2 groups:Group C and Group S.Patients in Group C will be preoxygenation with mask pressurized ventilation while patients in Group S with supraglottic jet ventilation by Wei NASAL JET（WNJ）.The tracheal intubation will be done after the 3 minutes preoxygenation. The investigators will measure the PaCO2 before and after preoxygenation, and the investigators will take the stomach-ultrasonography to find if there are too much gas in the gastro. If pulse oximetry is lower than 95% during the preoxygenation, the investigators will adjust the position of the Wei NASAL JET（WNJ) or use the change the way that the investigators hold the mask or change the pressure of ventilation on the basis of the group.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled for any surgery under general anesthesia
- •adults age range from 18-64 years old
- •American Society of Anesthesiologists Physical Status Classification (ASA class) I-II
- •voluntary participation in this clinical trail, signed informed consents
排除标准
- •patients with epistaxis, rhinostenosis, the episodes of rhinitis, severe gastroesophageal reflux disease, severe respiratory disease, severe cardiovascular and cerebrovascular disease
- •long-term use if anticoagulant drugs
- •can't cooperate with intervention
- •pulse oximetry <95% with normal respiration
研究组 & 干预措施
supraglottic jet ventilation group
Check blood gas before induction without preoxygen. Take stomach-ultrasound. Induction with Midazolam 0.02 mg/kg, sufentanil 0.3 ~ 0.5 ug/kg, propofol 2-2.5 mg/kg, rocuronium 0.6 mg/kg.After patients fall asleep and can't be woke up ,the investigators will put the Wei NASAL JET（WNJ）into one's nose to give the supraglottic jet ventilation with the driving pressure 0.01-0.03 megapascal (MPa), respiratory rate 15 beats per minute（BPM）, inspiratory/expiratory rate 1-1. 5.Check blood gas,stomach-ultrasound after 3 min, then do the tracheal intubation guided by visual laryngoscope.Stop jet ventilation during intubation.
干预措施: supraglottic jet ventilation (Device)
mask pressurized ventilation group
Check blood gas before induction without preoxygen. Take stomach-ultrasound. Induction with Midazolam 0.02 mg/kg, sufentanil 0.3 ~ 0.5 ug/kg, propofol 2-2.5 mg/kg, rocuronium 0.6 mg/kg.After patients fall asleep and can't be woke up ,the investigators will give them 1 min mask pressure respiration, by pressure control "V - E technique" after muscle relaxant. Check blood gas,stomach-ultrasound after 2 min, then do the tracheal intubation guided by visual laryngoscope.
结局指标
主要结局
alveolar oxygen tension（PaO2）
时间窗: baseline (before preoxygenation)
The results comes from blood gas analysis
alveolar oxygen tension（PaO2）
时间窗: 3 minutes after preoxygenation
The results comes from blood gas analysis
次要结局
- PaCO2(baseline (before preoxygenation))
- gastric antrum cross section(baseline (before preoxygenation))
- complications(1 day)
- PaCO2(3 minutes after preoxygenation)
- gastric antrum cross section(3 minutes after preoxygenation)
研究者
Hansheng Liang
Principal Investigator
Peking University People's Hospital