跳至主要内容
临床试验/CTRI/2025/12/098837
CTRI/2025/12/098837尚未招募不适用

Serial ultrasound assessment of gastric volume in pediatric patients at one and two hours after water intake: a prospective observational study.

AII India institute of medical sciences1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2025年12月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
33
试验地点
1
主要终点
Difference in mean gastric volume (mL/kg) between the 1 hour and 2 hour ultrasound assessments in the same pediatric patients.

研究概览

简要总结

The PG thesis synopsis for MD Anaesthesia  titled “Serial Ultrasound Assessment of Gastric Volume via Pediatric Patients at One and Two Hours after Water Intake: A Prospective Observational Study” aims to investigate gastric volume and pre induction changes in children at one and two hours following water ingestion, using bedside ultrasound. The study will be conducted in the pediatric age group of 3-10years. Children posted for general anaesthesia for elective surgery under general anaesthesia will be included after obtaining informed consent from parents/guardians.Participants will recieve water at 3ml/kg up to maximum of 200 ml .Patients will be assessed at 0 hour (baseline), 1 hour, and 2 hours post water ingestion in both supine and right lateral decubitus position . Gastric ultrasound will be performed to measure antral  cross sectional area and  gastric volume  using validated models (Perla’s grading) . A stomach is classified high risk if gastric volume is more than 1.5ml/kg and/or Perla’s grade 2. The study is important in evaluating fasting guidelines in children, since new evidence supports clear fluid intake up to one hour before anaesthesia. This study aims to contribute meaningful, evidence-based data in the Indian pediatric population to support safe, comfortable fasting protocols.

研究设计

研究类型
Observational

入排标准

年龄范围
3.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • · Children aged
  • 10 years · ASA physical status I or II · Scheduled for elective surgery under general anesthesia · Consent from parent or legal guardian.

排除标准

  • · Known gastrointestinal pathology (GERD, pyloric stenosis, delayed gastric emptying) · Diabetes mellitus or other metabolic disorders · Emergency surgeries · Refusal of consent.

结局指标

主要结局

Difference in mean gastric volume (mL/kg) between the 1 hour and 2 hour ultrasound assessments in the same pediatric patients.

时间窗: One hour and two hour

次要结局

  • Change in Perlas gastric volume grading between 1 and 2 hour post water intake(1 and 2 hour)
  • Proportion of children with an at-risk stomach at each time point defined as(Gastric volume more than 1.5 mL/kg or)
  • Correlation between antral CSA and calculated gastric volume at each time point.(1 and 2 hour)
  • Distribution of gastric volume types (empty, water, solid) at both intervals.(1 and 2 hour)
  • Influence of age, weight, and gender on gastric emptying and gastric volume(1 and 2 hour)

研究者

发起方
AII India institute of medical sciences
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Arushi Gautam

AIIMS Raipur

研究点 (1)

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