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临床试验/NCT03747796
NCT03747796已完成不适用

Evaluation of the Impact of Semi-sitting Position Versus Supine Position on Gastric Emptying in Children Using Gastric Ultrasound: a Randomized Controlled Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年11月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Number of children who have complete gastric emptying

研究概览

简要总结

The aim of this work is to evaluate the effect of semi sitting versus supine positions on gastric emptying of fluids in children using gastric ultrasound.

The investigators hypothesize that gastric emptying in children might be faster if the patient is in semi-sitting position. This hypothesis could impact the current guidelines for peri-operative fasting. Moreover, if this proved effective, could be used for enhancement of gastric emptying before emergency operations in non-fasting patient.

详细描述

Dealing with preoperative fasting requires a meticulous balance ensuring patient safety and lessening patient's discomfort. Although fasting is a basic requirement for avoiding pulmonary aspiration, it is sometimes associated with patient discomfort and hypoglycemia. According to the current guidelines for preoperative fasting of children, fasting is required for 2-hours, 4-hours, and 6-hours period after ingestion of water, breast milk, and infant formula respectively. Limited data is available for the effect of patient positioning on gastric emptying. A previous study had reported that gastric emptying of non-nutrient liquids was faster in the sitting position compared with the left lateral position . Another study showed similar findings after nutritive liquid and solid meals; whilst, a third study had reported that gravity has a little effect on gastric emptying.

In pediatric population the effect of posture on the duration of gastric emptying is not well investigated.

Gastric ultrasound is a valid, accurate, reproducible, non-invasive, bedside test for evaluation of the gastric volume. gastric ultrasound has been validated in adults as well as children for estimating the volume of gastric contents and evaluating gastric emptying.

The aim of this work is to evaluate the effect of semi sitting versus supine positions on gastric emptying of fluids in children using gastric ultrasound.

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 (Care Provider, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children 4 to 16 years of age.
  • Fasting for elective surgery.

排除标准

  • Gastrointestinal problems that may delay gastric emptying.
  • Recent abdominal operations.
  • Major systemic diseases which could impact gastric emptying.

研究组 & 干预措施

supine position

Active Comparator

The children will be in the supine position after ingestion of a standard volume of clear fluid.

干预措施: Supine position (Other)

Semi-sitting position

Experimental

The children will be in the semi-sitting position after ingestion of a standard volume of clear fluid.

干预措施: Semi-sitting position (Other)

结局指标

主要结局

Number of children who have complete gastric emptying

时间窗: 30 minutes after ingestion of clear fluid

Number of children who have complete gastric emptying defined as return of the antral cross-sectional area to the baseline reading

次要结局

  • Antral cross-sectional area corrected to the body weight(3 hours after ingestion of clear fluid)
  • Hunger satiety score(3 hours after ingestion of clear fluid)
  • Number of children who have complete gastric emptying(120 minutes after ingestion of clear fluid)

研究者

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

Ahmed Hasanin

Assistant professor of anesthesia and critical care

Cairo University

研究点 (2)

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