跳至主要内容
临床试验/NCT03310528
NCT03310528进行中(未招募)不适用

Gastric Ultrasound for Estimation of the Aspiration Risk in High Aspiration-risk Surgical Patient Populations

University of Florida1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
200
试验地点
1
主要终点
Changes in gastric content volume between the four groups assessed by ultrasound examination

研究概览

简要总结

The purpose of this research study is to look at the effectiveness of current anesthesia guidelines regarding food and drink prior to surgery in patients who are likely to have food and drink remain in their stomach longer than might ordinarily be expected.

详细描述

Examine the utility of ultrasound examination of the stomach in estimating aspiration risk in patient populations whose aspiration risk is currently poorly understood. Evaluate the applicability of current pre-surgical fasting guidelines in the same patient populations whose aspiration risk is poorly understood.

Evaluate the residual gastric contents in patients presenting for upper GI endoscopy procedures who have adhered to pre-operative fasting guidelines. Evaluate the residual gastric contents in patients presenting for upper GI endoscopy procedures who have not adhered to pre-operative fasting guidelines. Only patients expected to have an oral-gastric tube placed during upper GI endoscopy procedure will be included. Both groups will be evaluated to learn if their residual gastric contents conform to currently-accepted standards for low aspiration risk.

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presenting for upper GI endoscopy procedures or surgical repair of a trauma- related injury
  • Expected to have an oral-gastric tube placed as part of scheduled procedure
  • Willing to undergo an ultrasound exam
  • Patients ≥ 18 years of age

排除标准

  • Unwilling to undergo an ultrasound exam
  • Oral-gastric tube placement is not indicated
  • Oral-gastric tube placement is contraindicated
  • Pregnant patients and patients from defined vulnerable populations (ex. pediatric patients, mentally handicapped patients, prisoners, etc.)
  • Surgical trauma patients who are not expected to have an OG tube placed during surgery
  • Patients with history of gastric bypass surgery
  • Patients that are gastrostomy tube dependent

结局指标

主要结局

Changes in gastric content volume between the four groups assessed by ultrasound examination

时间窗: Up to 12 hours

Evaluate the residual gastric contents in patients presenting for upper GI endoscopy procedures to learn if their residual gastric contents conform to currently-accepted standards for low aspiration risk.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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