Optimization for Laryngeal Mask Removal Strategy and Evaluation of Transitional Criteria From PACU in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- baseline heart rate
研究概览
简要总结
Laryngeal mask airway(LMA) is now a widely accepted airway device in general anesthesia for children. LMA removal after operation is always practiced in post-anesthesia-care-unit(PACU). The removal timing depends on recovery of spontaneous respiration and wash-out of inhalation anesthetics. This study focuses on the optimization for LMA removal strategy. Moreover, this study also discusses the transitional criteria from PACU to the ward.
详细描述
The study recruits 180 children aged under 6-year-old undergoing elective general anesthesia. Laryngeal mask is used in procedure. The children are carried into PACU to get monitored and removal the LMA. The children are randomized into 4 groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Children aged under 6 years old undergoing selected eye surgery
- •Scheduled for general anesthesia
排除标准
- •With systemic disease
- •Respiratory system deformity
- •Respiratory infection in 4 weeks
结局指标
主要结局
baseline heart rate
时间窗: before induction
heart rate before induction
heart rate LMA removal
时间窗: immediately after LMA removed
heart rate when LMA removed
heart rate when transited out PACU
时间窗: before transited out of PACU (last measured data in PACU)
heart rate out PACU
heart rate spontaneous respiratory
时间窗: immediately after recovering spontaneous respiratory
heart rate when spontaneous respiratory recovers
baseline mean blood pressure
时间窗: before induction
mean blood pressure before induction
mean blood pressure after induction
时间窗: immediately after induction
mean blood pressure after induction
heart rate after induction
时间窗: immediately after induction
heart rate after induction
heart rate in procedure
时间窗: in procedure
heart rate in procedure
heart rate when transited into PACU
时间窗: immediately after transited into PACU (first measured data in PACU)
heart rate into PACU
heart rate effective spontaneous respiratory
时间窗: immediately after effective spontaneous respiratory recovers
heart rate when effective spontaneous respiratory recovers
mean blood pressure in procedure
时间窗: in procedure
mean blood pressure in procedure
mean blood pressure when transited into PACU
时间窗: immediately after transited into PACU (first measured data in PACU)
mean blood pressure into PACU
mean blood pressure when transited out PACU
时间窗: before transited out of PACU (last measured data in PACU)
mean blood pressure out PACU
mean blood pressure spontaneous respiratory
时间窗: immediately after effective spontaneous respiratory recovers
mean blood pressure when effective spontaneous respiratory recovers
mean blood pressure LMA removal
时间窗: immediately after LMA removed
mean blood pressure when effective spontaneous respiratory recovers
time length of LMA removal
时间窗: from the time point of the child be transited into PACU until the time point of the LMA be removed
time length from the child transited into PACU to LMA removal
desaturation
时间窗: from the time point of the LMA be removed until the time point of the child be transited out of PACU
desaturation count and severity
clenching
时间窗: from the time point of the LMA be removed until the time point of the child be transited out of PACU
clenching during LMA removal
dwell time length in PACU
时间窗: from the time point of the child be transited into PACU until the time point of the child be transited out of PACU
time length of the child staying in PACU
cough
时间窗: from the time point of the LMA be removed until the time point of the child be transited out of PACU
cough count and severity
gross body movement
时间窗: from the time point of the LMA be removed until the time point of the child be transited out of PACU
gross body movement during LMA removal
breath holding
时间窗: from the time point of the LMA be removed until the time point of the child be transited out of PACU
breath holding during LMA removal
airway obstruction
时间窗: from the time point of the LMA be removed until the time point of the child be transited out of PACU
airway obstruction
次要结局
- parents' satisfaction score(up to 3 days after surgery)
- sleep quality score(up to 3 days after surgery)
- FLACC(face,legs,activity,cry,consolability) scale score(up to 3 days after surgery)
- anxiety score(up to 3 days after surgery)