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临床试验/NCT05435157
NCT05435157已完成不适用

Comparative Observational Study of Residual Gastric Volume Measured by Ultrasound After Preoperative Fasting in a Diabetic Surgical Population Versus a Non-diabetic Surgical Population.

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León1 个研究点 分布在 1 个国家目标入组 592 人开始时间: 2022年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
592
试验地点
1
主要终点
Residual Gastric Volume

研究概览

简要总结

Comparison of residual gastric volume measure by ultrasounds between diabetic and non-diabetic patients scheduled for elective surgery

详细描述

The presence of gastric content increases the risk of aspiration during general anesthesia. Delayed gastric emptying has been described in diabetic patients; for that reason, diabetic patients could have a high risk of aspiration despite adequate fasting. This study aimed to compare ultrasound-guided measurement of residual gastric volume between diabetic and non-diabetic patients scheduled for elective surgery.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • •BMI<40 kg.m-2;
  • •Age over 18 years;
  • •American Society of Anesthesiologists' physical status status I-III
  • •who were to undergo elective surgery and had the ability to understand the rationale of the study and provide informed consent

排除标准

  • •Pregnancy
  • •Recent upper gastrointestinal bleed (< 1 month)
  • •Abnormal anatomy of the upper gastrointestinal tract (such as hiatal hernias and gastric tumors)
  • •Previous surgical procedures on the esophagus, stomach, or upper abdomen
  • •Gastroesophageal reflux disease
  • •Previous use of prokinetics or high doses of opiates.

研究组 & 干预措施

Diabetic patients

Diabetic patients undergoing scheduled surgery

Non-diabetic patients

Non-diabetic patients undergoing sheduled surgery

结局指标

主要结局

Residual Gastric Volume

时间窗: Preoperative

Residual gastric volume measured by ultrasounds as follows: Volume (mL) = 27.0 + 14.6 × CSARLD (cm²) - 1.28 × age (years)

次要结局

  • Antral Cross-Sectional Area(Preoperative)

研究者

发起方
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose Alfonso Sastre

Principal Investigator

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

研究点 (1)

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