Comparison of Gastric Insufflation Volume Between LarySeal Pro and Ambu AuraGain Using Ultrasonography In Pediatric Patients Undergoing General Anesthesia With Controlled Ventilation. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- gastric antrum cross-sectional area (CSA) in cm²
研究概览
简要总结
Gastric air insufflation during insertion of a laryngeal mask airway (LMA) is a known phenomenon and can have important clinical implications, especially in relation to: During positive pressure ventilation or improper insertion technique, air can be forced into the esophagus and stomach or LMAs do not fully seal the esophagus, so high ventilation pressures or incorrect placement may lead to gastric insufflation. Which may lead to Increased risk of regurgitation and aspiration, especially if the gastric contents reach the upper esophagus, Abdominal distension, which can reduce ventilation efficiency, nausea, vomiting, or delayed gastric emptying postoperatively which detected by Epigastric auscultation may reveal gurgling sounds during ventilation, Gastric ultrasound can visualize the extent of gastric insufflation and Capnography sometimes shows altered patterns if regurgitation begins . This complication prevented by:
- Use low-pressure, controlled ventilation (<20 cmH₂O).
- Ensure proper size and positioning of the LMA.
- Use second-generation LMAs (like LarySealPro or Ambu AuraGain LMA) that have gastric drainage ports to relieve air.
Consider gastric ultrasound preoperatively to assess risk . (1)
Several studies have assessed the performance of Ambu AuraGain and LarySeal Pro individually or in comparison with other supraglottic airway devices. Ambu AuraGain, a second-generation device with a gastric drainage channel, has demonstrated high oropharyngeal leak pressures and ease of insertion, making it suitable for positive pressure ventilation. LarySeal Pro has also shown favorable results in terms of low airway resistance and effective sealing in adults. However, direct comparisons between these two devices are limited, especially regarding gastric insufflation volume measured by ultrasonography, which offers objective and quantitative assessment. Although some adult studies have evaluated AuraGain against devices like ProSeal or i-gel, there is a notable lack of pediatric studies directly comparing AuraGain and LarySeal Pro using gastric ultrasound techniques.(2) To date, no published randomized controlled trials have directly compared gastric insufflation volumes between Ambu AuraGain and LarySeal Pro using ultrasonography in pediatric patients under general anesthesia. This represents a critical gap in the literature, given the increased risk of aspiration in children and the growing use of ultrasound to evaluate perioperative gastric content.
Compared to Endotracheal intubation , SADs offer reported advantages such as simplicity in insertion, elimination of neuromuscular blocking agents, enhancement of spontaneous respiration, and avoidance of translaryngeal positioning accompanied by cardiovascular effects and close vocal cord contact. reduced rate of laryngospasm and a lower incidence of postoperative hoarse voice, coughing and sore throat. (3)
Despite this, the use of these device may be associated with various complications as regurgitation and aspiration of gastric contents, compression of vascular structures, trauma, and nerve injury.(4). The LMA can be a useful airway device in pediatric patients as well as adults, despite clear differences between the anatomy of the pediatric and adult airway. Sizes I, 2, and 2 1/2 are available for use in infants and children. In general, children require greater anesthetic depth prior to placement . The LMA can be placed successfully in children after either an inhalational or intravenous induction of anesthesia. (5) Ambu AuraGain and LarySeal Pro are designed with a cuff modified to improve the seal around the glottis and a drainage tube to provide a bypass channel for regurgitated gastric contents, prevent gastric insufflation, and allow the passage of a gastric tube. These features are designed to improve the safety of the mask and broaden its scope, especially when used with positive pressure ventilation.(6) Aim of the work The aim of the study is to compare the gastric insufflation volume between the LarySeal Pro Laryngeal Mask and Ambu AuraGain Laryngeal Mask in pediatric patients undergoing general anesthesia with controlled ventilation.
Objectives:
To assess and compare gastric insufflation volume between LarySeal Pro laryngeal mask and Ambu AuraGain laryngeal mask in pediatric patients using pelviabdominal ultrasound undergoing general anesthesia.
Hypothesis We hypothesize that LarySeal Pro laryngeal mask produce gastric insufflation volume less than Ambu AuraGain laryngeal mask in pediatric patients undergoing general anesthesia.
详细描述
I. Study design Randomized Controlled Clinical Trial II. Study setting and location The location of where the study will be conducted (Pediatric Specialized Hospital, Cairo University) III. Study population This section should describe the target population, including patients who are between 2-10 years old undergoing general anesthesia with controlled ventilation.
IV. Eligibility Criteria
- Inclusion criteria
- Age: pediatrics (2-10 years )
- Patients with a Mallampati score of I - II
- Elective surgeries
- Short procedure expected to last for 1 hour or less .
- ASA I - II
- Exclusion criteria • Age: below 2 years and above 12 years
- Patient with airway masses
- Active upper respiratory tract infections, pneumonia, COPD & exacerbated bronchial asthma.
- Patient with gastroesophgeal reflux ( hiatus hernia , achalasia )
- Patient with abnormal airway anatomy
- Coagulation disorders.
- Patients with any cardiac conditions (IHD, RHD, decompensated heart failure and arrhythmia).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization will be done by computer generated numbers and concealed by serially numbered, opaque and sealed envelopes. The details of the series will be unknown to the investigators and the group assignment will be kept in asset of sealed envelopes each bearing only the case number on the outside, and divided into 2 equal groups:
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Age: pediatrics (6-12years )
- •Patients with a Mallampati score of I - II
- •Elective surgeries
- •Short procedure expected to last for 1 hour or less .
- •ASA I - II
排除标准
- •• Age: below 6 years and above 12 years
- •Patient with airway masses
- •Active upper respiratory tract infections, pneumonia, COPD & exacerbated bronchial asthma.
- •Patient with gastroesophgeal reflux ( hiatus hernia , achalasia )
- •Patient with abnormal airway anatomy
- •Coagulation disorders.
- •Patients with any cardiac conditions (IHD, RHD, decompensated heart failure and arrhythmia).
研究组 & 干预措施
Ambu AuraGain
Before induction of anesthesia, a gastric antrum ultrasound will be performed to assess gastric air volume by measuring the cross-sectional area of the gastric antrum in a supine position. The measurements will be taken between antral contractions to provide an accurate baseline value.In operation room, routine monitoring is established before induction of anesthesia . Group B receiving the Ambu AuraGain.Induction of general anesthesia will be achieved by inhalation induction by sevoflurane then securing IV access by proper sized cannula then all patients will received Fentanyl 1ug/kg, Propofol 2mg/kg and,tracium 0.5mg/kg. Mechanical ventilation will be employed be kept below <15 (cmH2O) to avoid gastric insufflation.Postinsertion gastric (CSA) in the supine position will be measured using ultrasound after laryseal pro insertion and before removal.Then record readings pre and postop insertion then compare between 2 devices regarding gastric antral volume.
干预措施: Ambu aura (Device)
Larysealpro
: Before induction of anesthesia, a gastric antrum ultrasound will be performed to assess gastric air volume by measuring the cross-sectional area of the gastric antrum in a supine position. The measurements will be taken between antral contractions to provide an accurate baseline value.In operation room, routine monitoring is established before induction of anesthesia . Either Group A, receiving the LarySeal Pro laryngeal mask Induction of general anesthesia will be achieved by inhalation induction by sevoflurane then securing IV access by proper sized cannula then all patients will received Fentanyl 1ug/kg, Propofol 2mg/kg and,tracium 0.5mg/kg. Mechanical ventilation will be employed be kept below <15 (cmH2O) to avoid gastric insufflation.Postinsertion gastric (CSA) in the supine position will be measured using ultrasound after laryseal pro insertion. Then record readings pre and post insertion and post operative then compare between 2 devices regarding gastric antral volume
干预措施: LarySeal Pro (Device)
结局指标
主要结局
gastric antrum cross-sectional area (CSA) in cm²
时间窗: 6 months
gastric antrum cross-sectional area (CSA) in cm²was measured before induction of general anesthesia, before supraglottic airway devices (SAD) insertion, and at the end of surgery before SAD removal.
次要结局
- .Time of insertion of supraglottic airway devices in seconds .Percentage of Failure rate for each device.Monitoring the intraoperative hemodynamics HR and BP every 3 min .Monitoring the intraoperative ropharyngeal leak pressure(6 months)
- Incidence of vomiting, Incidence of bleeding, Incidence of aspiration, Incidence of bronchospasm and Incidence of hoarseness of voice in percentage(6 months)
研究者
Mahmoud Gbre
lectrer of anesthesia faculty of medicine cairo universty
Cairo University