The Correlation of Gastric Residual Volume Detected by Preoperative Gastric Ultrasonography With Body Mass Index and Aspiration Risk in Patients Undergoing Laparoscopic Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The correlation between BMI, gastric residual volume, and aspiration risk.
研究概览
简要总结
Obesity is a chronic, complex disease defined by the World Health Organization (WHO) as the excessive accumulation of fat in the body that can harm health. Since 1975, the prevalence of obesity has been increasing worldwide, making it a significant public health issue. Body mass index (BMI) is important in diagnosing obesity. BMI is calculated by dividing a person's weight (kg) by the square of their height (m²). BMI: weight (kg) / height² (m²). According to the WHO, a BMI between 30.0-34.9 kg/m² is classified as Class 1 obesity, between 35.0-39.9 kg/m² as Class 2 obesity, between 40-49.9 kg/m² as Class 3 obesity, and ≥50.0 kg/m² as super obesity.
Obesity is closely related to increasing morbidity and mortality worldwide, and in obese patients, the incidence of diseases such as type 2 diabetes, hypertension, cardiovascular disease, dyslipidemia, coronary heart disease, obstructive sleep apnea, asthma, depression, other psychiatric disorders, and gastroesophageal reflux has increased. Treatment options for obesity include lifestyle changes, specific diets, diet-drug combinations, metabolic and various bariatric surgical options. Among these treatment options, metabolic and bariatric surgical procedures are considered the most effective methods for weight loss.
Aspiration of gastric contents is a significant perioperative complication that can cause up to 9% of anesthesia-related deaths. Due to delayed gastric emptying in obese patients, the risk of aspiration is higher compared to non-obese patients. In obese patients, preoperative anesthesia management is more challenging, and the risk of pulmonary aspiration is greater. Since obesity is an independent risk factor for patients with a full stomach, and airway management can be difficult in these patients, it is essential to assess the aspiration risk in the preoperative period.
Anesthesia guidelines recommend that to improve the quality and effectiveness of anesthesia care and reduce the severity of potential complications related to perioperative pulmonary aspiration of gastric contents, adults and children should be allowed to drink clear liquids up to 2 hours before elective surgery, and solid food consumption should be prohibited 6 hours before elective surgery.
Recently, with the integration of ultrasound into anesthesia practice, ultrasound has been applied in various surgical procedures and clinical conditions. The use of ultrasound to evaluate the risk of aspiration in the preoperative period and to determine the residual gastric volume is increasingly being used in clinical practice. The use of gastric ultrasound to assess aspiration risk has also been increasing in pediatric patient groups and pregnant patients, similar to obese patient groups.
In this study, the investigators' aim is to determine the relationship between BMI, fasting duration, and aspiration risk by assessing the gastric residual volume in the preoperative period through gastric ultrasonography in patients with obesity who will undergo bariatric surgery.
详细描述
Patients will be informed about the study procedure one day before the surgery, and informed consent will be obtained from those who agree to participate. For patients who have given consent, gastric ultrasonography will be performed in the anesthesia preparation room before surgery. The examination will be conducted first in the supine position and then in the right lateral decubitus (RLD) position.
While patients are in the RLD and supine positions, a low-frequency (2-5 MHz) curved ultrasound probe will be used to scan from left to right along the subcostal margin. The left lobe of the liver and the descending abdominal aorta will be used as anterior and posterior landmarks. Gastric content will be evaluated both qualitatively and quantitatively by gastric ultrasonography.
In the RLD position, two maximum perpendicular diameters of the stomach-anteroposterior (AP) and craniocaudal (CC)-will be measured. The antral cross-sectional area (CSA) in the right lateral decubitus position will be calculated using the formula:
CSA = (AP × CC × π) / 4.
Gastric residual volume will then be calculated using the formula by Perlas et al.:
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will undergo bariatric surgery under general anesthesia in elective conditions
- •Patients in ASA II-III groups, with BMI > 35 kg/m², and aged between 18-65 years
- •Patients who have provided informed consent
排除标准
- •Patients under 18 years of age, over 65 years of age, or in ASA IV-V groups
- •Pregnancy
- •Patients with upper gastrointestinal (GI) abnormalities such as hiatal hernia and gastric tumors
- •Patients with a recent history of upper GI bleeding (within the last 12 months), previous stomach and esophagus surgeries, or abnormal anatomy of the upper gastrointestinal tract
- •Patients using medications that affect gastric motility or other related conditions
- •Patients with uncontrolled diabetes
- •Patients who require emergency surgery
- •Patients with advanced cardiac, renal, pulmonary, or hepatic failure
- •Patients who refuse to participate and do not provide informed consent
结局指标
主要结局
The correlation between BMI, gastric residual volume, and aspiration risk.
时间窗: 5 minutes
Higher BMI levels may be associated with increased gastric residual volume (GRV), which in turn can elevate the risk of pulmonary aspiration, especially during anesthesia. Understanding the correlation between BMI, GRV, and aspiration risk is crucial for developing safer preoperative fasting guidelines and optimizing care in high-risk patients.
次要结局
- The correlation between fasting duration, gastric residual volume, and the risk of aspiration(5 minutes)
研究者
Büşra Tanacıoğlu
Research Assistant MD
Fatih Sultan Mehmet Training and Research Hospital