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临床试验/NCT06600035
NCT06600035招募中不适用

Gastric Ultrasound in Elective Surgical Diabetic Patients

Tanta University1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年9月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
130
试验地点
1
主要终点
Antral cross-sectional area (CSA)

研究概览

简要总结

The aim of this study is to evaluate the role of gastric ultrasound in elective surgical diabetic patients.

详细描述

Aspiration of gastric contents during perioperative period is a grave complication with significant morbidity and mortality. The overall incidence of gastric content aspiration ranges between <0.1% and 19% and aspiration pneumonia account for 9% of all anesthesia-related mortality. Mendelson described the pathophysiological mechanisms of pulmonary aspiration, which led to the development of strategies to prevent pulmonary aspiration.

Consequently, American Society of Anesthesiologists (ASA) released preoperative fasting guidelines for healthy patients undergoing elective surgery, in order to reduce gastric content volume and minimize the risk of aspiration. However, there are still many situations where the ASA fasting guidelines may be not suitable, including urgent or emergency situations and medical conditions such as diabetes mellitus.

Ultrasound is widely available and has been proven to be a reliable, bedside assessment tool for real-time evaluation of gastric contents. As diabetic patients are prone to have an inadequately empty stomach even after an adequate fasting, ultrasound can be used prior to induction for screening the fasting gastric volume (GV) of diabetic patients and see if it is more than the recommended safe limit.

As a novel point-of-care application, ultrasound sonography allows anesthesiologists to evaluate a patient's gastric content and volume at the bedside and helps guide anesthetic and airway management.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years.
  • Both sexes.
  • Undergoing elective surgery.

排除标准

  • American Society of Anesthesiology (ASA) physical status >III.
  • Body mass index (BMI) outside the range of 18.5-40 Kg/m
  • History of upper gastrointestinal disease or previous surgery on the esophagus, stomach, or upper abdomen.
  • Abnormalities of the upper gastrointestinal tract, such as gastric tumors and recent upper gastrointestinal bleeding (within the preceding 1 month).
  • Taking preoperative medicines that may delay gastric emptying (e.g., anticholinergic agents, opioids).
  • Hypothyroidism.
  • Current smoking history.
  • Pregnancy.

结局指标

主要结局

Antral cross-sectional area (CSA)

时间窗: Just before surgery

Cross-sectional area (CSA) will be calculated by using two perpendicular diameters-anteroposterior (AP) and craniocaudal (CC) and the formula for area of an ellipse: CSA = (AP × CC × π)/4

次要结局

  • Gastric volume(Just before surgery)
  • Gastric volume/weight(Just before surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Said ElSharkawy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

研究点 (1)

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