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临床试验/NCT05737641
NCT05737641已完成不适用

Ultrasonographic Evaluation of Gastric Content and Volume After Oral Ingestion of Water or Jelly in Volunteers - A Randomised Controlled Non-inferiority Clinical Trial

Centro Hospitalar de Entre o Douro e Vouga2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年12月1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
25
试验地点
2
主要终点
gastric antral cross-sectional area

研究概览

简要总结

The aim of this study is to determine whether the fasting duration required for patients after consuming oral jelly is comparable to that after consuming water, prior to elective surgery.

International guidelines for perioperative fasting recommend abstaining from clear fluids for 2 hours to minimize the risk of regurgitation and aspiration pneumonia. However, there are no specific recommendations regarding the perioperative management of jelly consumption.

Current understanding emphasizes the benefits of minimizing preoperative fasting time, including preventing dehydration and metabolic complications like ketoacidosis, as well as potentially enhancing patient satisfaction.

Oral jelly consumption may offer advantages by improving preoperative hydration and providing some nutritional support prior to procedures.

This crossover study will involve 25 adult volunteers. In the first phase, participants will be randomly assigned to either oral intake of water or jelly, followed by the opposite intervention in the second phase. Gastric content and volume will be assessed using gastric ultrasound.

详细描述

Prolonged preoperative fasting is associated with unfavorable outcomes, inducing a catabolic state that may lead to metabolic disturbances such as ketoacidosis, insulin resistance, dehydration, and increased postoperative complications such as surgical site infection and delayed bowel function. To minimize fasting time, current guidelines from the American Society of Anesthesiology advise clear fluid intake (water, tea, coffee, pulp-free fruit juices, carbohydrate-rich beverages) up to 2 hours prior to elective procedures involving general anesthesia, regional anesthesia, or procedural sedation and analgesia. Solids fasting should extend to 6 to 8 hours, depending on the type of foods.

Jelly is a solid food, mostly composed of water. Among its other components, proteins, responsible for its solidification, and sugars stand out. Thus, it may be a form of oral hydration, associated with some nutritional value, but the appropriate preoperative fasting time is not explicitly stated in the guidelines.

An important cause of mortality and morbidity associated with tracheal intubation is the aspiration of gastric contents. It is important to ensure that restricting preoperative fasting time does not compromise patient safety, thereby increasing this risk. While carbohydrate-rich beverages are not associated with delays in gastric emptying, the same cannot be said for protein-containing liquids.

Gastric ultrasound is a non-invasive, bedside-available, and reliable method for quantitative and qualitative assessment of stomach contents. Although the minimum volume of gastric contents associated with increased risk of aspiration is not known, some studies demonstrate that volumes up to 1.5 mL/kg of clear fluids, in the absence of solid contents, are normal, commonly seen in fasting adults, and are not associated with an increased risk of pulmonary aspiration.

The aim of our study is to demonstrate that jelly ingestion, compared to water, is not associated with larger cross-sectional area of the gastric antrum, behaving similarly to clear fluids.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult volunteers working in the hospital Centro Hospitalar de Entre o Douro e Vouga (CHEDV)

排除标准

  • morbid obesity
  • pregnancy
  • alcohol abuse
  • diseases or drugs that can prolong or accelerate gastric emptying such as gastric or esophageal surgery, diabetes mellitus, prokinetic or opioid use, hypothyroidism
  • intolerance to any of the components of jelly

结局指标

主要结局

gastric antral cross-sectional area

时间窗: 2 hours after intervention

antral cross-sectional area measured by ultrasound in right lateral decubitus position (non-inferiority test)

次要结局

  • gastric volume(2 hours after intervention)
  • hunger and thirst(2 hours after intervention)
  • Qualitative gastric evaluation(2 hours after intervention)
  • gastric volume greater than 1.5 mL/Kg(2 hours after intervention)

研究者

发起方
Centro Hospitalar de Entre o Douro e Vouga
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paulo Jorge Gomes Correia

Dr. Paulo Correia

Centro Hospitalar de Entre o Douro e Vouga

研究点 (2)

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