NCT06527352已完成不适用
Comparison of Risk of Gastroesophageal Reflux During General Anesthesia With Tulip vs GMA(Glottis Mask Airway) Airway
Air Force Military Medical University, China1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- pH value of secretion on the tip of glottis mask airway at the end of surgery
研究概览
简要总结
Glottis mask airway (GMA) is supraglottic airway device and is frequently used in patients undergoing general anesthesia. However, gastroesophageal reflux remains a risk during ventilation through supraglottic airway devices. The classical shaped GMA and tulip shaped GMA differ in the shape of their tips. And theoretically the tulip shaped tip fits the larynx better. This study aims to compare the incidence of gastroesophageal reflux during ventilation through classical shaped vs tulip shaped glottis mask airway.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age≥18 years old
- •scheduled for surgery under general anesthesia with laryngeal mask airway
排除标准
- •American society of anesthesiologists status score higher than 3
- •morbid obesity (body mass index higher than 40 kg/m2)
- •with high risk of gastroesophageal reflux
- •with risk of difficult airway
- •with airway disease
研究组 & 干预措施
classical shaped mask airway
Other
干预措施: classical shaped (Other)
tulip shaped mask airway
Other
干预措施: glottis mask airway (Device)
tulip shaped mask airway
Other
干预措施: tulip shaped (Other)
classical shaped mask airway
Other
干预措施: glottis mask airway (Device)
结局指标
主要结局
pH value of secretion on the tip of glottis mask airway at the end of surgery
时间窗: at the end of surgery
次要结局
- Oropharyngeal leak pressure(from insertion of glottis mask airway to start of surgery, at an average of 10 minutes)
- incidence of glottis airway mask related adverse events by 24 hours after surgery(24 hours after surgery)
- number of insertion to achieve successful positioning of glottis mask airway(from taking of glottis mask airway to inserting it to appropriate position, at an average of 1 minute)
- number of needs for modulating the position of glottis airway mask during surgery(from insertion of glottis mask airway to end of surgery, at an average of 2 hours)
- scale of difficulty of inserting gastric tube(from insertion of glottis mask airway to start of surgery, at an average of 10 minutes)
- score of satisfaction of anesthesiologist to glottis airway mask(from insertion of glottis mask airway to withdrawal of glottis airway mask, at an average of 2 hours)
- number of participants with a pH value of secretion on the tip of glottis mask airway less than 4.1(at the end of surgery)
- duration of establishing appropriate ventilation(from taking of glottis mask airway to inserting it to appropriate position, at an average of 1 minute)
- incidence of epiglottis suppression(from insertion of glottis mask airway to start of surgery, at an average of 10 minutes)
- duration of inserting glottis mask airway(from taking of glottis mask airway to inserting it to appropriate position, at an average of 1 minute)
- incidence of blood on the tip of glottis airway mask(from end of surgery to withdrawal of glottis airway mask, at an average of 5 minutes)
研究者
Zhihong LU
Associate professor
Air Force Military Medical University, China
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Gastric Insufflation and Laryngeal Mask AirwayGastric InsufflationNCT02097771Lionel Bouvet
尚未招募
3 期
a novel airway device for for diagnostic trans esophageal echocardiography in pediatricsPACTR202008749509618Dr. Mona Raafat Elghamry140
尚未招募
不适用
Comparison of Gastric Insufflation With the Classic Igel Laryngeal Mask and the New Igelplus Laryngeal Mask Using Gastric UltrasoundSurgeryAnesthesiaNCT06578598Luzerner Kantonsspital200
已完成
不适用
A Study Comparing the Laryngeal Mask Airway Supreme With the Laryngeal Mask Airway Protector In the Ambulatory Surgery UnitAirway Complication of AnesthesiaNCT03462550University Hospital, Ghent80
Unknown
不适用
Self-pressurised Air-Q With Blocker Versus Baska Mask in Low Risk Female Patients Undergoing Ambulatory Surgery.Supraglottic Airway DevicesNCT03798392Cairo University62