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临床试验/NCT06008509
NCT06008509招募中不适用

Determination of Gastric Content Using Ultrasonography in Patients Undergoing Emergency Surgery

Pontificia Universidad Catolica de Chile2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年4月24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
300
试验地点
2
主要终点
Number of patients with properative full stomach and type of content that they present

研究概览

简要总结

The goal of this clinical trial is to learn about the gastric emptying in adult patients that are going to operatin theatre due to an abdominal acute disease, for instance, intestinal obstruction or cholecystitis. This kind of patients are traditionally considered as a full stomach and the induction of anesthesia include rapid sequence intubation (RSI) in order to decrease the risk of aspiration . However, image technologies, like echography, allow the visualization of the stomach and to measure the amount and characteristics of the content lodged in the stomach. This information is vital to decide if RSI is necesary or not. The main question[s] it aims to answer are:

  • What is the percentages of full stomach in patient who come to the operating room due an abodiminal acute disease?
  • Are different variables, namely, time since diagnosis, use of antibiotics or non steroidal antiinflamatory drugs related with the content of the stomach? Participants will be evaluated with ecography to determinate the amount of content of the stomach before the surgery in the operating room.

详细描述

The pulmonary aspiration of gastric contents is a serious anesthetic complication with high associated morbidity and mortality. Its incidence is estimated to be between 0.1% and 19% of cases of general anesthesia. It is associated with admission to intensive care units, prolonged mechanical ventilation, and mortality, which can reach up to 5%. On the other hand, it accounts for 9% of anesthesia-related death). Given this, in patients at risk of aspiration, such as non-compliance with fasting or acute abdominal pathology, rapid sequence induction is routinely used. However, this technique is not without risks, being associated with episodes of desaturation, hyperkalemia, among others. Therefore, it is reasonable to question the widespread use of this technique in all urgent surgeries for acute abdominal pathologies, based solely on the pathophysiological concept that inflammation and pain could be associated with delayed gastric emptying and therefore a higher risk of aspiration, especially in high-risk populations for desaturation and difficult airway, such as pediatric patients or pregnant women.

The use of ultrasound for determining gastric content is a feasible tool to assess the risk of aspiration. The best results have been obtained using curved transducers, with the patient in a semi-sitting or right lateral decubitus position, where the evaluation of the gastric antrum has shown better sensitivity in detecting content in patients with prolonged fasting. Multiple studies have been conducted in adult and pediatric patients, including obstetric and obese patients, for whom the technique could be more challenging, achieving high sensitivity and specificity in determining gastric content with ultrasound based on standardized measurements of the antrum. The purpose of this study is to describe the percentage of patients that have full stomach just befor the induction of the anesthesia and to evaluate if preoperatory treatments and time since the diagnosis are related with the gastric emptying.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults patients
  • Emergency surgery
  • Diagnosis of Acute Abdomen

排除标准

  • Younger than 18 years old
  • No posibility of adopt lateral decubitus.

结局指标

主要结局

Number of patients with properative full stomach and type of content that they present

时间窗: Through study completion, an average of 1 year

Number of patients that present full stomach determinated by a mathematical formula obtained by a prior study of Perlas et al, according to the gastric perimeter measured in centimeters. In case of the stomach present content by the formula, the contet will be described in three categories: Solid, liquid or difusse.

次要结局

  • Relation between some interventions, for instance: use of antibiotics, antiinflamatory drugs and time of fasting with gastric emptying.(through study completion, an average of 1 year)

研究者

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

Alejandro Luengo

Clinical Professor

Pontificia Universidad Catolica de Chile

研究点 (2)

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