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临床试验/NCT06666049
NCT06666049招募中不适用

Gastric POCUS for Airway Management in Patients Using Glucagon-like Peptide-1 Receptor Agonist (Multicentric)

Clinica Universidad de Navarra, Universidad de Navarra3 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2024年10月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
39
试验地点
3
主要终点
Gastric Ultrasound

研究概览

简要总结

1. Introduction

Scheduled surgery requires patients to undergo a preoperative fasting period of at least 6 hours to reduce the risk of perioperative pulmonary aspiration. However, certain medications and conditions may delay gastric emptying, potentially increasing aspiration risk. These include diabetic gastroparesis and the use of glucagon-like peptide-1 (GLP-1) receptor agonists for the treatment of diabetes and obesity.

GLP-1 receptor agonists are widely used due to their beneficial effects on glycemic control and weight reduction. However, one of their known effects is delayed gastric emptying, which may result in increased residual gastric content despite adherence to standard fasting guidelines. Recent reports have described cases of pulmonary aspiration during anesthesia in patients receiving GLP-1 receptor agonists, even after appropriate fasting.

Given the increasing use of these medications, there is a need for objective assessment tools to evaluate gastric content in the perioperative setting. Gastric ultrasonography has emerged as a non-invasive bedside technique that may help identify patients at increased risk of aspiration and guide airway management strategies.

详细描述

2. Hypothesis

Gastric ultrasonography performed by trained anesthesiologists is a useful tool for assessing gastric content and may support clinical decision-making in airway management in patients treated with GLP-1 receptor agonists.

3. Methodology

This is a prospective, observational cohort study conducted at participating centers.

The study population consists of adult patients undergoing scheduled surgery under general anesthesia following a standard preoperative fasting period.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults patients ,ASA I-III, taking GLP-1 analog medications, undergoing scheduled surgery.

排除标准

  • - History of esophagogastric pathology or previous abdominal surgery.
  • - Hiatal hernia/gastroesophageal reflux disease.
  • - Autonomic nervous system disorders.
  • - Neurological or neuromuscular diseases.
  • - Use of medications/drugs that affect autonomic regulation and delay gastric emptying (opioids) or potentiate it (prokinetics).
  • - Pregnancy.
  • - Presence of arrhythmias.

研究组 & 干预措施

Treatment with GLP-1 agonists

Patients undergoing treatment with GLP-1 agonists, from any geographical area, who choose to undergo scheduled and/or urgent surgery under general anesthesia and/or sedation at our hospital over a two-year period (2024-2025).

干预措施: Gastric Ultrasound (Diagnostic Test)

结局指标

主要结局

Gastric Ultrasound

时间窗: 5 minutes

Gastric ultrasonography performed by trained anesthesiologists, for measuring gastric content in volume (cm3) is a useful tool for assessing gastric content and making clinical decisions regarding airway management.

Gastric Ultrasound

时间窗: Immediately prior to induction of anesthesia

Gastric ultrasonography performed by trained anesthesiologists, for measuring gastric content in volume (cm3) is a useful tool for assessing gastric content and making clinical decisions regarding airway management.

次要结局

  • Height in centimeters(1 minute)
  • weight in kilograms(1 minute)
  • BMI in kg/m^2(1 minute)
  • weight in kilograms(Immediately prior to induction of anesthesia)
  • Height in centimeters(Immediately prior to induction of anesthesia)
  • BMI in kg/m^2(Immediately prior to induction of anesthesia)

研究者

发起方
Clinica Universidad de Navarra, Universidad de Navarra
申办方类型
Other
责任方
Sponsor

研究点 (3)

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