跳至主要内容
临床试验/NCT07555080
NCT07555080招募中不适用

Comparison of Gastric Volume Changes Via Ultrasound After Ventilation With Endotracheal Tube, First-Generation Supraglottic Airway, and Second-Generation Supraglottic Airway in Pediatric Patients: A Prospective Observational Study

Istanbul University2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2026年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
2
主要终点
Comparison of Gastric Volume Changes Among Study Groups

研究概览

简要总结

This study aims to compare the gastric volumes of pediatric patients undergoing positive-pressure ventilation with different airway management techniques. Gastric ultrasound is a non-invasive bedside tool with high sensitivity and specificity for determining the nature and amount of gastric content. In pediatric cases, maintaining a gastric volume below 1.25 mL/kg is associated with a lower risk of perioperative aspiration.

Although supraglottic airway devices (SADs) are commonly used as alternatives to endotracheal tubes, concerns regarding the potential for gastric insufflation and subsequent aspiration persist. Second-generation SADs were specifically designed with gastric drainage channels to mitigate the risk of regurgitation compared to first-generation devices.

The primary objective of this study is to determine whether there is a difference in gastric volumes, as measured by ultrasound, among three groups of pediatric patients: those managed with endotracheal tubes, first-generation SADs, and second-generation SADs. By comparing these measurements post-ventilation, the investigators aim to evaluate the impact of the airway device choice on gastric volume under clinical conditions.

详细描述

All participants will receive a standard preoperative intravenous (IV) dose of 0.1 mg/kg midazolam in the preparation room. Upon arrival at the operating room, routine monitoring will be established for all patients, including electrocardiography (ECG), non-invasive blood pressure (NIBP), and peripheral oxygen saturation (SpO2). Before the induction of anesthesia (T0), the gastric antral area will be evaluated using ultrasound in the right lateral decubitus (RLD) position. A high-frequency linear probe will be placed sagittally in the epigastric region to visualize the stomach antrum, located posterior to the left lobe of the liver and anterior to the abdominal aorta. The largest and smallest diameters (d1 and d2) of the elliptical antrum will be measured. The Antral Cross-Sectional Area (ACSA) will be calculated using the formula: ACSA = d1*d2*pi/4. Gastric volume will then be derived using the validated pediatric formula: [0.035*ACSA (mm2) + 0.127*age (months) - 7.8] / body weight (kg). Standard general anesthesia induction will be performed using sevoflurane and oxygen inhalation, 1 mcg/kg IV fentanyl, and 0.5 mg/kg IV rocuronium. Following induction, patients will be managed with either endotracheal intubation or a supraglottic airway device (SAD). The choice of airway management will follow routine clinical practice. SAD size and cuff inflation volume will adhere to the manufacturer's recommendations. Any volume leakage during ventilation will be recorded as a percentage. Anesthesia maintenance will be provided with 1 MAC sevoflurane in an oxygen/air mixture. The gastric antral area will be re-evaluated via ultrasound in the RLD position at two additional time points: T1: Immediately after the airway device is secured and ventilation is established, before the start of surgery. T2: At the end of the surgical procedure, before the patient emerges from anesthesia. All relevant clinical data will be recorded in the patient follow-up form, including age, gender, height, weight, duration of surgery, vital signs, type of airway device used, perioperative airway pressures, and any observed complications. Following the final measurement, patients will be emerged from anesthesia and transferred to the postoperative recovery room according to standard protocols.

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

入选标准

  • 1-10 years of age
  • Adherence to standard preoperative fasting guidelines
  • Elective surgeries
  • ASA I-III status
  • Surgery time 30 min to 2 hours

排除标准

  • Gastrointestinal tract surgeries
  • Laparoscopic surgeries
  • Emergency procedures
  • Full stomach patients
  • Lack of parental/guardian consent

研究组 & 干预措施

First-generation supraglottic airway

Patients ventilated via a first-generation supraglottic airway

Second-generation supraglottic airway

Patients ventilated via a second-generation supraglottic airway

Endotracheal intubation tube

The patients who ventilated by endotracheal tube

结局指标

主要结局

Comparison of Gastric Volume Changes Among Study Groups

时间窗: up to 2 hours

The primary outcome is to compare the change in gastric volume which calculated via ultrasound at T0 (before induction), T1 (after airway secured) and T2 (end of the operation) among the three groups (Endotracheal tube, first generation supraglottik airway device(SAD) and second generation SAD). This will determine if the choice of airway device leads to a difference in gastric volume accumulation during the perioperative period.

次要结局

  • Correlation Between Duration of Surgery and Change in Gastric Volume(30 minutes to 2 hours)
  • Antral cross sectional area changes(up to 2 hours)
  • Air leakege(up to 2 hours)
  • Airway pressures(up to 2 hours)
  • Heart rate(up to 2 hours)
  • Airway complications(up to 3 hours)
  • SpO2(up to 2 hours)
  • Mean arteryal pressure(up to 2 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meltem Savran Karadeniz

Professor

Istanbul University

研究点 (2)

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