Preoperative Ultrasound Evaluation of Gastric Contents in Voluntary Termination of Pregnancy (IVG) During the First Trimester: Prospective Observational Study of Patients With Gestational Nausea and Vomiting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Prediction of gastric content by ultrasound
研究概览
简要总结
This is an observational, prospective, monocentric, diagnostic study aiming to evaluate the diagnostic properties of the presence of nausea-vomiting in predicting the existence of gastric contents in preoperative surgical abortion.
详细描述
Most surgical abortions are performed under general anaesthesia. Inhalation of gastric contents is one of the main complications of general anesthesia, in terms of frequency and severity. Patients in the 1st trimester of pregnancy are frequently subject to nausea and vomiting, even on an empty stomach. The presence of nausea and vomiting prior to surgery means that the anesthetic protocol needs to be modified, as there is a greater risk of complications, particularly allergic ones. Preoperative gastric ultrasound is recognized for its ability to predict the risk of gastric inhalation during anesthesia. It is a non-irradiating, non-invasive, painless and rapid examination. There are no data on the association between gestational nausea and vomiting and the risk of inhalation in the context of preoperative fasting. There are no data on the gastric volume of patients in the 1st trimester of pregnancy with or without nausea. Does gestational nausea and vomiting represent an anesthetic risk of gastric inhalation?
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •Patients undergoing Voluntary termination of pregnancy by dilatation and aspiration before 14 weeks of amenorrhea
排除标准
- •Patient under guardianship or curatorship.
- •Patient with language barrier.
- •Any condition causing the patient to be considered as having a "full stomach" even before the gastric ultrasound:
- •body mass index (BMI) > 40 kg/m2
- •Hiatal hernia.
- •History of gastric or esophageal surgery or neoplasia.
- •Gastroparesis (diabetic, hepatocellular insufficiency, severe renal insufficiency, etc.).
- •Opposition of the patient to the re-use of her data for the study.
结局指标
主要结局
Prediction of gastric content by ultrasound
时间窗: Day 0
according to the presence of nausea or vomiting : Sensitivity, specificity, positive and negative predictive values
次要结局
- Prevalence of presence of gastric content(Day 0)
- Anesthesia protocol(Day 0)
- nausea or vomiting(Day 0)
- Respiratory complications(At discharge from the recovery room up to one hour)