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临床试验/NCT04159636
NCT04159636已完成不适用

Comparison of the Risk of Pulmonary Aspiration Assessed by Gastric Ultrasound in Elderly Patients in Fasting Group vs. Carbohydrate Loading Group

Kangbuk Samsung Hospital2 个研究点 分布在 2 个国家目标入组 58 人开始时间: 2020年1月7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
58
试验地点
2
主要终点
Incidence of risk of pulmonary aspiration assessed by gastric ultrasound defined by Perlas grade 2

研究概览

简要总结

The aim of this study was to compare the risk of pulmonary aspiration assessed with gastric ultrasonography in elderly patients, undergoing elective surgery.

详细描述

Recently, carbohydrate loading is suggested for enhanced recovery after surgery.

Aging process often accompanies gastrointestinal dysmotility. Therefore, elderly patients might have undiagnosed gastro-esophageal reflux disease, or other gastrointestinal disorders. Moreover, because of their co-morbid underlying diseases and multi-drug effects, gastric emptying might be further delayed in the elderly patients.

This study was designated to compared the risk of pulmonary aspiration in elderly patients, with gastric ultrasound between fasting group and carbohydrate loading group.

研究设计

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

入排标准

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

入选标准

  • aged from 65
  • scheduled for elective surgery
  • American Society of Anesthesiologists physical status 1 or 2

排除标准

  • Diagnosed for diseases that might delay gastric emptying (obesity, diabetes, hiatal hernia, gastro-esophageal reflux disease, ileus)
  • psychiatric or mental disorders
  • parkinsonism
  • alcoholism
  • drug abuse

结局指标

主要结局

Incidence of risk of pulmonary aspiration assessed by gastric ultrasound defined by Perlas grade 2

时间窗: 2 hours after intake of last allowable carbohydrate drink time

Incidence of Perlas grade 2. Clear fluid is detected in gastric antrum by gastric antral ultrasound on both supine and right lateral decubitus position. Perlas grade 2: fluid appears in both supine and right lateral decubitus positions Perlas grade 1: fluid is detected only in right decubitus position Perlas grade 0: fluid is not detected in both supine and right lateral decubitus positions.

次要结局

  • cross-sectional area of gastric antrum in right decubitus position(2 hours after intake of last allowable carbohydrate drink time)
  • cross-sectional area of gastric antrum in supine position(2 hours after intake of last allowable carbohydrate drink time)

研究者

发起方
Kangbuk Samsung Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eunah Cho, MD

Clinical Assistant Professor

Kangbuk Samsung Hospital

研究点 (2)

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