ULTRASOUND ASSESSMENT of GASTRIC CONTENT in FASTED PREGNANT WOMEN: PROSPECTIVE OBSERVATIONAL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 主要终点
- Qualitative assessment of the antrum of the stomach
研究概览
简要总结
The risk of pulmonary aspiration of gastric contents remains a significant risk during anesthesia, especially in pregnant women, as they may often require surgery without having observed appropriate fasting. A bedside ultrasound assessment of the status of the gastric content would be of great value for the clinician.
This prospective observational study aimed to (1) qualitatively and quantitatively describe the sonographic appearance of the gastric antrum in fasted high-risk pregnant women during the third trimester and (2) evaluate the relationship between demographic and clinical variables and the gastric antral cross-sectional area (CSA).
详细描述
The aim of this prospective study is to provide a qualitative and quantitative description of the sonographic appearance of the gastric antrum in fasted high-risk pregnant women in the 3rd trimester.
The investigators expect that the information obtained from the systematic ultrasonographic qualitative/quantitative assessment of the gastric content may help anesthesiologist to better assess aspiration risk and guide anesthetic and airway management, particularly in pregnant women scheduled for elective Cesarean delivery after standard preoperative fasting guidelines.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non-labouring pregnant women at 3rd trimester (≥ 28 weeks)
- •18 years or older.
- •ASA physical status I-III
- •Hospitilized in High Risk Pregnancy Department
- •Ability to understand the rationale of the study assessments and provide signed informed consent.
- •Written informed consent
排除标准
- •Patients with American Society of Anesthesiology (ASA) physical status class IV.
- •Patient age < 18 years
- •Pregnant patients with upper gastrointestinal (GI) disease and pathology.
- •History of upper GI tract surgical procedures.
- •History of medications that affect gastrointestinal motility.
- •Inability to understand the rationale of the study assessments and provide signed informed consent.
结局指标
主要结局
Qualitative assessment of the antrum of the stomach
时间窗: 10 min
Patients will be classified as follows; Grade 0: the antrum appears empty on both supine and right lateral decubitus positions; grade 1: gastric fluid is visible on the right lateral decubitus position only, suggesting a small fluid volume; and grade 2: gastric fluid is observed in the antrum in both supine and right lateral decubitus, suggesting a larger fluid volume.
次要结局
- Quantitative assessment of the antrum of the stomach(10 min)
研究者
Maxim Glebov
Dr.
The Chaim Sheba Medical Center