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临床试验/NCT04228497
NCT04228497已完成不适用

Ultrasound Assessment of Gastric Residual Volume in Children Scheduled for Elective Surgery After Clear Fluids Fasting for One Versus Two Hours; a Comparative Study

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 226 人开始时间: 2020年1月1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
226
试验地点
1
主要终点
GRV in right lateral position after one-hour clear fluid intake.

研究概览

简要总结

Ultrasound guided comparison of gastric residual volume after clear fluid fasting for one versus two hours in pediatrics scheduled for elective surgery.

详细描述

Introduction:

The traditional 2-hour clear fluid fasting time was recommended by almost all anesthesia societies [1-3] to decrease the risk of pulmonary aspiration. However, these recommendations are based on historical adult literature [4,5] that may not be applicable to the pediatric population. Moreover, recent studies have shown that these recommendations may not be properly applied, and many children could have been starving for long intervals before surgery with the current guidelines [6-8] which was associated with increased risk of post induction hypotension during surgical preparation [9,10] There is a growing evidence that more liberal clear fluids intake does not result in significant increase in the risk of pulmonary aspiration [11,12] while children may have less thirst, hunger, anxiety, postoperative nausea and vomiting[13-15] also, limiting the fasting time may improve the perioperative inflammatory response in children [16].

Hence, a consensus statement was issued by the Association of Pediatric Anesthetists of Great Britain and Ireland (APAGBI), the European Society of Pediatric Anesthetists and the French-Language Society of Pediatric Anesthesiologists; encouraging clear fluids to be given up to 1 hour before elective general anesthesia [17] which was followed by the Canadian Pediatric Anesthesia Society (CAPS) statement in 2019 [18], however, these statements have not been translated into guidelines to date until further evidence is released.

Gastric residual volume GRV can be used as a preoperative tool for assessment of the risk of perioperative pulmonary aspiration in clinical practice [19]. Many methods have been used to assess gastric volume in pediatrics including nasogastric aspiration [20] , magnetic resonance imaging (MRI) and ultrasound[19,21]. Of these, only ultrasound is of clinical utility because it is simple, bedside, reliable [22], safe tool and allows both qualitative and quantitative assessment of gastric contents [19,23,24].

So, we aim to assess GRV in pediatrics having clear fluids fasting for one hour before elective surgery. We hypothesize that clear fluids fasting for one hour will not result in a clinically significant increase in GRV compared to two hours fasting for children scheduled for elective surgery under general anesthesia.

研究设计

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

入排标准

年龄范围
3 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • • ASA physical state I or II
  • Age 3 to 10 years.
  • Gender: both sexes.
  • Scheduled for non-GIT elective day-case surgery under general anesthesia with endotracheal intubation.

排除标准

  • • Parent/ care giver refusal
  • Ages < 3 or > 10 years old
  • Children with gastro-esophageal reflux disease (GORD): either on treatment or under investigation
  • Renal failure, Diabetes mellitus and cerebral palsy patients
  • Esophageal strictures, achalasia or any intestinal disease that may impair the gastric emptying.
  • GIT surgery and neurosurgical patients
  • Emergency surgery

结局指标

主要结局

GRV in right lateral position after one-hour clear fluid intake.

时间窗: one-hour of clear fluid intake

次要结局

  • Gastric residual volume in supine position in both groups(one hour after clear fluid intake)
  • Antral cross-sectional area in right lateral position after one-hour clear fluid intake(one-hour clear fluid intake)
  • Grade of aspiration risk (frequency of high risk and low risk)(one and two hours after clear fluid intake)
  • Qualitative grading for assessment of gastric antrum: three-point grading will be evaluated(one and two hours after clear fluid intake)
  • incidence of aspiration and or vomiting(10 minutes from induction of anesthesia)
  • Antral cross-sectional area in right lateral and supine positions after two hours clear fluid intake(two hours clear fluid intake)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Khaled Abdelfattah Abdallah Sarhan

principal investigator

Kasr El Aini Hospital

研究点 (1)

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