Airway Management Effects of Flexible Reinforced Laryngeal Mask Airway Versus Endotracheal Tube for Childhood Adenotonsillectomy：a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Petco2
研究概览
简要总结
The goal of this clinical trial is to compare the airway management effects of flexible reinforced laryngeal mask and endotracheal tube in childhood adenotonsillectomy.
Participants will be randomly allocated to two groups: endotracheal tube group (ETT) and flexible reinforced laryngeal mask group (FLMA). For those in ETT group: they will be intubated after induction of anesthesia .For those in FLMA group: they will be put in flexible reinforced laryngeal mask after induction of anesthesia .
The investigators will compare FLMA with ETT to see if flexible reinforced laryngeal mask can be used safely and effectively in childhood adenotonsillectomy，and if there will be less severe adverse events in FLMA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •patients who choose to have adenotonsillectomy surgery
- •the American Society of Anesthesiologists (ASA) physical status ranked I-II
- •the oropharyngeal anatomy is normal
- •competent to provide informed consent
排除标准
- •upper respiratory tract infection one week before surgery
- •oropharyngeal anatomy is abnormal
- •high risk of reflux aspiration
- •liver or kidney failure
- •psychiatric disorders
结局指标
主要结局
Petco2
时间窗: intraoperative period,10 minutes-1 hour
Petco2 at the end of surgery
Peak airway pressure
时间窗: intraoperative period,10 minutes-1 hours
Maximum peak airway pressure during surgery
Ventilation leakage or not
时间窗: intraoperative period,10 minutes-1 hour
Using volume ventilation, tidal volume set to 10 ml /kg, Ventilation leakage is defined as reaching more than 20% of the set tidal volume.
次要结局
- Mean arterial pressure (MAP)(Intraoperative period, 30 minutes - 1.5 hours)
- Heart rate (HR)(Intraoperative period, 30 min - 1.5 hours)
- Extubation time(Postoperative 30 minutes)
- Success of FLMA or ETT(Intraoperative period, 10 minutes - 1hour)
- Surgeon satisfaction(Postoperative 30 minutes)
- Recovery time(Postoperative 30 minutes)
- Dosage of anesthetic(Intraoperative period, 30 minutes - 1.5 hours)
- Adverse events(Postoperative 1 hour)
研究者
Li Na
Deputy Chief Physician
Maternal and Child Health Hospital of Hubei Province