The Effect of Two Different Airway Management on Oxygenation During Deep Sedation in Patients Undergoing Hysteroscopy, Based on Oxygen Reserve Index Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The incidence of low oxygen saturation
研究概览
简要总结
Hysteroscopy is used to examine and treat uterine diseases. Because of severe pain due to uterine distention and cervical dilatation, deep sedation usually be provided during this procedure. Respiratory depression and upper airway obstruction are main respiratory complications during deep sedation. Face mask and nasopharyngeal airway are main airway management during deep sedation. Oxygen reserve index is a non-invasive parameter, it reflects the moderate hyperoxia statues. In this study, investigators compare the effect of face mask and nasopharyngeal airway management on oxygenation during deep sedation in participants undergoing hysteroscopy. Investigators also investigate whether oxygen reserve index monitoring reduce the incidence of hypoxemia.
详细描述
Randomization:
Participants are divided into four groups: face mask airway management without oxygen reserve index (ORi) monitoring group (FM-ORi group), face mask airway management with ORi monitoring group (FM+ORi group), nasopharyngeal tube airway management without ORi monitoring group (NT-ORi group), nasopharyngeal tube with ORi monitoring group (NT+ORi group).
Deep sedation process:
Participants fasting solid and liquid for 8 and 4 hours respectively. Electrocardiogram (ECG), oxygen saturation (SpO2), blood pressure (BP) and bispectral index (BIS) were monitored. Sufentanil 5 μg injected for 30 seconds, followed by target-control infusion of propofol (plasma target concentration 3-6 ug/ml) to maintain BIS between 50-70. Criteria for deep sedation: participants have purposeful response after repeated and/or painful stimulation, there is minimal effect on hemodynamic stability.
Airway management:
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, 18-60 years old
- •Scheduled for hysteroscopy
- •Predict operation duration more than 10 minutes
排除标准
- •Participants refuse
- •Predict the presence of difficult airway
- •Combined with obstructive sleep apnea syndrome
- •Combined with upper respiratory tract infection, and/or pulmonary inflammation
- •Combined with chronic obstructive pulmonary disease
- •Combined with asthma
- •Body mass index (BMI) >30 kg/m2
- •Coagulation dysfunction, and/or undergo anticoagulant therapy
- •Nasal deformity
- •Pregnancy, positive urine pregnancy test
研究组 & 干预措施
face mask airway management without oxygen reserve index monitoring
Participants inhale oxygen through face mask at a flow rate of 5 L/min and will be monitored with oxygen saturation.
干预措施: face mask ventilation (Procedure)
face mask airway management without oxygen reserve index monitoring
Participants inhale oxygen through face mask at a flow rate of 5 L/min and will be monitored with oxygen saturation.
干预措施: oxygen saturation monitoring (Device)
face mask airway management with oxygen reserve index monitoring
Participants inhale oxygen through face mask at a flow rate of 5 L/min and will be monitored with oxygen reserve index.
干预措施: face mask ventilation (Procedure)
face mask airway management with oxygen reserve index monitoring
Participants inhale oxygen through face mask at a flow rate of 5 L/min and will be monitored with oxygen reserve index.
干预措施: oxygen reserve index monitoring (Device)
nasopharyngeal tube airway management without oxygen reserve index monitoring
Participants inhale oxygen through face mask before induction and through nasopharyngeal tube after consciousness disappear at a flow rate of 5 L/min and will be monitored with oxygen saturation.
干预措施: nasopharyngeal tube ventilation (Procedure)
nasopharyngeal tube airway management without oxygen reserve index monitoring
Participants inhale oxygen through face mask before induction and through nasopharyngeal tube after consciousness disappear at a flow rate of 5 L/min and will be monitored with oxygen saturation.
干预措施: oxygen saturation monitoring (Device)
nasopharyngeal tube airway management with oxygen reserve index monitoring
Participants inhale oxygen through face mask before induction and through nasopharyngeal tube after consciousness disappear at a flow rate of 5 L/min and will be monitored with oxygen reserve index.
干预措施: nasopharyngeal tube ventilation (Procedure)
nasopharyngeal tube airway management with oxygen reserve index monitoring
Participants inhale oxygen through face mask before induction and through nasopharyngeal tube after consciousness disappear at a flow rate of 5 L/min and will be monitored with oxygen reserve index.
干预措施: oxygen reserve index monitoring (Device)
结局指标
主要结局
The incidence of low oxygen saturation
时间窗: Procedure (from anesthesia induction to anesthesia recovery)
oxygen saturation less than 95% last for at least 10 seconds
次要结局
- Total duration of assist ventilation(Procedure (from anesthesia induction to anesthesia recovery))
- The lowest oxygen saturation(Procedure (from anesthesia induction to anesthesia recovery))
研究者
Guan Zheng
the first affiliated hospital of xi'an jiaotong university
First Affiliated Hospital Xi'an Jiaotong University