Effect of I-gel and Air-Q SP LMAs on Oropharyngeal Leak Pressure and Gastric Insufflation in Children: An Ultrasonography-Guided Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Oropharyngeal Leak Pressure (OLP)
研究概览
简要总结
This study aims to compare two commonly used airway devices (I-gel and Air-Q) in children aged 1-10 years undergoing general anesthesia for surgery. These devices help doctors keep the airway open and support breathing during the operation. The study will evaluate how well each device works, how easy they are to place, and whether they cause air to enter the stomach. Ultrasound will be used to safely check the position of the device and detect any air in the stomach. The results of this study may help improve the safety and effectiveness of airway management in children during anesthesia.
详细描述
This study is designed to compare two commonly used airway devices, I-gel and Air-Q, in children aged 1-10 years who are undergoing surgery under general anesthesia. These devices are used by anesthesiologists to keep the airway open and allow safe breathing during the procedure. Although both devices are widely used in clinical practice, their performance and safety in children may differ.
In this study, children will be randomly assigned to receive one of the two devices during anesthesia. The researchers will measure how effectively each device seals the airway, how easy and quick it is to place, and whether it causes air to enter the stomach, which can be an unwanted effect. Ultrasound imaging, a safe and non-invasive method, will be used to assess both the position of the device and the presence of air in the stomach.
All procedures performed in this study are part of standard clinical care, and no additional risks beyond routine anesthesia practice are expected. The information obtained from this study may help doctors choose the most effective and safest airway device for children, thereby improving the quality of anesthesia care and reducing potential complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 1-10 years
- •American Society of Anesthesiologists (ASA) physical status I-II
- •Scheduled for elective (non-emergency) surgery under general anesthesia
- •Planned use of a supraglottic airway device for airway management
- •Written informed consent obtained from a parent or legal guardian
排除标准
- •History of conditions associated with increased risk of aspiration (e.g., gastroesophageal reflux)
- •Known or predicted difficult airway (e.g., Mallampati score ≥ 3)
- •Congenital or acquired abnormalities of the face, neck, or upper airway
- •Active upper respiratory tract infection
- •Presence of significant pulmonary disease (e.g., asthma, bronchopulmonary dysplasia, cystic fibrosis)
- •Body mass index above the 95th percentile for age (morbid obesity)
- •Emergency surgery
- •Previous complications related to supraglottic airway device use
- •Failure of device placement or need to switch to an alternative airway management technique
- •Refusal of participation by parent or legal guardian
研究组 & 干预措施
I-Gel Group
Participants in this group will receive the I-gel laryngeal mask airway during general anesthesia. After placement, oropharyngeal leak pressure will be measured, and ultrasonography will be used to assess device position and detect gastric insufflation. Additional parameters such as insertion time, ease of insertion, and perioperative complications will be recorded.
干预措施: I-gel supraglottic airway device (Device)
Air-Q SP Group
Participants in this group will receive the Air-Q SP laryngeal mask airway during general anesthesia. Similar measurements will be performed, including oropharyngeal leak pressure, ultrasonographic evaluation of device position and gastric insufflation, insertion time, ease of insertion, and perioperative complications.
干预措施: Air-Q SP supraglottic airway device (Device)
结局指标
主要结局
Oropharyngeal Leak Pressure (OLP)
时间窗: Immediately after device placement and at the end of the surgical procedure during anesthesia
Measured in cmH₂O after device placement and at the end of surgery using standard anesthesia machine settings (fresh gas flow 3 L/min, APL valve set to 30 cmH₂O).
次要结局
- Gastric Insufflation(Immediately after device placement and at the end of surgery)
- Device Position(Immediately after device placement, after patient positioning, and at the end of surgery)
- Insertion Time(At the time of device placement (periprocedural))
- Ease of Insertion(At the time of device placement (periprocedural))
- Perioperative Complications(From device placement until discharge from the Post-Anesthesia Care Unit (PACU), up to 2 hours)
研究者
Ulku Yavuz Ersayin
M.D.
Ankara Etlik City Hospital