Comparing the Effect of Laryngeal Tube Suction (LTS) and Air-Q sp3G Laryngeal Mask Airway (LMA) Use on Gastric Insufflation and Volume Using Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Gastric Antral Cross Sectional Area (T0)
研究概览
简要总结
The primary objective of the study is to evaluate gastric insufflation during the use of two different airway devices (Laringeal Tube Suction and Air Q sp3G Laryngeal Mask.
The secondary objectives of the study are to assess these two airway devices in terms of perioperative complications.
详细描述
During general anesthesia, various devices are used to secure the airway. Supraglottic airway devices (SGAs) are among these and are used safely for short surgical procedures. Although SGAs are used to provide an easy and safe airway, none of them seal the trachea and ventilate only the lungs in the way that endotracheal intubation (ETT) does. Positive pressure ventilation provided at the supraglottic level cannot prevent air from escaping into the esophagus and, consequently, the stomach. Gastric distension is associated with perioperative complications such as nausea, vomiting, and aspiration, and is considered an undesirable condition by anesthesiologists.
The study aims to compare the Laryngeal Tube Suction and the Air Q sp3G Laryngeal Mask in terms of gastric insufflation. By measuring the diameters of the gastric antrum and recording their changes throughout the case, this study intend to evaluate the effectiveness and reliability of the two airway devices.
ASA (American Society of Anesthesiologist) I-III class pediatric patients between the ages of 1-12 who will undergo elective surgery under general anesthesia will be included in the study. Randomisation will be done with a sealed envelope. The blinded researcher will collect and record data without knowing which airway device was chosen. Blind researcher will do gastric ultrasound measurements with Butterfly IQ+ ultrasound. Another researcher will insert the airway device and after insertion patients head will be covered, this researcher will not involve during data collection. After the data is collected, the airway device releated data will be recorded by non-blind researcher seperately.
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
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an ASA score of I-III for whom a supraglottic airway (SGA) is planned.
- •Operation time less than 2 hours. Patients who have read and accepted the informed consent form. Patients between the ages of 1 and 12, or their guardians, will be included in the study.
排除标准
- •Patients who do not meet perioperative fasting criteria. Patients whose stomachs are not considered empty during the initial gastric ultrasound.
- •Patients with a known difficult airway. Patients with oropharyngeal or laryngeal anomalies. Patients who require the use of neuromuscular blockers. Patients with a history of a previously failed SGA placement. Patients with known reflux. Patients who do not give consent will not be included in the study.
研究组 & 干预措施
AIRQ
After obtaining consent, patients will be asked to choose their airway device using a sealed envelope method. The patients' demographic data and ASA scores will be recorded. Gastric antrum diameters will be recorded at the beginning of the case, before induction. After the airway device is placed, the antrum diameters will be recorded. The antrum diameters will be recorded again after the surgery is complete, before the airway device is removed. Mechanical ventilator settings will be recorded. To ensure standardization, the tidal volume will be set to 7 ml per kg. No PEEP will be applied. Volume-controlled ventilation will be used. The lowest intraoperative saturation and the highest peak pressure that occurred will be recorded.The cuff pressure will be recorded after being inflated with the recommended volume. The time taken for airway device placement (the time from when it is picked up until Endtidal CO2 is observed) and any failed placements will be recorded.
LTS
After obtaining consent, patients will be asked to choose their airway device using a sealed envelope method. The patients' demographic data and ASA scores will be recorded.
Gastric antrum diameters will be recorded at the beginning of the case, before induction. After the airway device is placed, the antrum diameters will be recorded. The antrum diameters will be recorded again after the surgery is complete, before the airway device is removed.
Mechanical ventilator settings will be recorded. To ensure standardization, the tidal volume will be set to 7 ml per kg. No PEEP will be applied. Volume-controlled ventilation will be used. The lowest intraoperative saturation and the highest peak pressure that occurred will be recorded.The cuff pressure will be recorded after being inflated with the recommended volume.
The time taken for airway device placement (the time from when it is picked up until Endtidal CO2 is observed) and any failed placements will be recorded.
结局指标
主要结局
Gastric Antral Cross Sectional Area (T0)
时间窗: Just before anesthesia induction
First gastric measurement: Before anesthesia induction gastric ultrasound will be done and gastric antrum cross sectional area will be recorded by blinded researcher
Gastric Antral Cross Sectional Area (T2)
时间窗: Just before the end of anesthesia, after the surgery is completed
Third measurement: Just before the end of anesthesia, after the surgery is completed gastric ultrasound will be done and gastric antrum cross sectional area will be recorded by blinded researcher.
Gastric Antral Cross Sectional Area (T1)
时间窗: Right after the SGA is placed following anesthesia induction.
Second gastric measurement: after anesthesia induction and before the start of surgery gastric ultrasound will be done and gastric antrum cross sectional area will be recorded by blinded researcher
次要结局
- LTS Cuff Pressure Measurement(Just after inserting a Laryngeal Tube Suction)
- Maximum Airway Pressure (PPeak)(Intraoperative)
- Minimum Saturation(Intraoperative)
- Spasm(Intraoperative and/or postoperative 2 hours)
- The time taken for airway device placement and failed placement(Intraoperative)
- Postoperative Sore Throat(Postoperative 2 hours)
- Postoperative Nausea and Vomitting(Postoperative 2 hours)
- Presence of blood on the supraglottic airway(Just after removing the SGA)
- Postoperative Cough(Postoperative 2 hours)
- Need for nebulized medications or cool mist.(Postoperative 2 hours)