Quantitative Ultrasound Assessment of Gastric Volume in Diabetic and Non Diabetic Patients Scheduled for a General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 245
- 试验地点
- 3
- 主要终点
- Number of patients with full stomach
研究概览
简要总结
The main objective is to compare the frequency of a " full stomach " in diabetic patients compared with a control population, all the patients having followed the instructions of preoperative fast.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged over 18
- •American Society of Anesthesiologists (ASA) classification 1 to 3
- •Needed a general anesthesia for a programmed surgical intervention
- •Respect of instructions of the pre-operative fasting;
- •Affiliation to the social security;
- •Consent form signed
- •Non inclusion Criteria:
- •Pregnant or breastfeeding women
- •Patients already operated or to be operated from the upper digestive tract (esophagus, stomach, duodenum)
- •Patients treated with a prokinetic treatment and / or a level 3 analgesic
排除标准
- •Unfeasibility to ultrasound measurement of antral area
- •Failure to observe fasting instructions
研究组 & 干预措施
Diabetic patient
Diabetic patients (type 1 or type 2 diabetes) with scheduled surgery . Ultrasonic measurement of antral area
干预措施: Ultrasonic measurement of antral area (Procedure)
Non diabetic patient
Patients with scheduled surgery without history of diabetes or a current, treated or untreated, diabetic disease.
Ultrasonic measurement of antral area
干预措施: Ultrasonic measurement of antral area (Procedure)
结局指标
主要结局
Number of patients with full stomach
时间窗: one day
The main objective is to compare the frequency of a "full stomach" in the diabetic population compared to a "control" population just before induction of general anesthesia. A "full stomach" is defined by an antral area \> 340 mm2 The main objective is to compare the frequency of a "full stomach" in the diabetic population compared to a "control" population just before induction of general anesthesia. A "full stomach" is defined by an antral area \> 340 mm2
次要结局
- Glycated hemoglobin(one day)
- Fast duration(one day)
- Glycemia(one day)
- Evaluation of anxiety using a numerical scale (from 0 -no anxiety- to 10 -maximal anxiety-)(one day)
- Evaluation of anxiety using a numerical scale (from 0 -no pain- to 10 -maximal pain-)(one day)
- Intraoperative hypoxemia(one day)