Effect of Head-neck Rotation on the Success Rate At First Attempt of I-gel™ Insertion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- First attempt success rate
研究概览
简要总结
According to previous studies, head and neck rotation reduces the tongue from being rolled back by gravity, which resulted in increasing patency of the upper airway. Therefore, the purpose of this study is to verify whether head and neck rotation increases the first attempt success rate of i-gel™.
详细描述
I-gel™ insertion has been reported that the success rate of insertion on the first attempt is 78.5%. There may be several causes of insertion failure. Tongue folding is a major obstacle preventing appropriate i-gel™ placement. To solve this problem, the previous study has proven the efficacy of the rotational technical for I-gel™ insertion and reported a success rate of 97%.
However, the rotation of i-gel™ in the oral cavity may be limited, and it may take some learning curve to get used to it. According to previous studies, head and neck rotation increases the cross-sectional area of the upper airway, which resulted in increasing patency of the upper airway. Therefore, the purpose of this study is to verify whether head and neck rotation increases the first attempt success rate of i-gel™.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA Physical Status Classification Grade 1-3
- •Patients who can provide written consent to participate in clinical trials
- •Patients requiring the I-gel™ during surgery
排除标准
- •Outpatient surgery
- •Patients who have the neurologic disease or cognitive impairment
- •Patients who take antipsychotic drugs
- •Body mass index > 35 kg/m2
- •Mouth opening < 2.5 cm
- •Limited neck extension or cervical mobilization (Ex: Atlanto-axial subluxation, History of cervical spine surgery or head and neck surgery)
- •Those with a recent sore throat
- •Those with weak dentation
- •Patients at risk of aspiration (Ex: Pregnancy, Gastroesophageal reflux disease or hiatus hernia)
结局指标
主要结局
First attempt success rate
时间窗: Induction of anesthesia during intraoperative period
After the first attempt on insertion of i-gel™ without withdrawal or redirection, the effectiveness of the airway is judged based on a square-wave capnograph and no audible leak with peak airway pressures ≥ 10 cmH2O during manual ventilation.
次要结局
- Change to intubation(Induction of anesthesia during intraoperative period)
- Blood staining after extubation(Induction of anesthesia during intraoperative period)
- Sore throat after extubation(Extubation during intraoperative period)
- Hoarseness after extubation(Extubation during intraoperative period)
- Time required for successful insertion; s(Induction of anesthesia during intraoperative period)
- Insertion time for successful insertion; s(Induction of anesthesia during intraoperative period)
- Manipulations required rate(Induction of anesthesia during intraoperative period)
- Second attempt success rate(Induction of anesthesia during intraoperative period)
- Third attempt success rate(Induction of anesthesia during intraoperative period)
- Third attempt(Induction of anesthesia during intraoperative period)
- Sore throat at 24 hours after surgery(24 hours after surgery (up to 24hours))
- Hoarseness at 24 hours after surgery(24 hours after surgery (up to 24hours))
研究者
Karam Nam, MD
Seoul National University Hospital
Seoul National University Hospital