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临床试验/NCT04544371
NCT04544371已完成不适用

Evaluation of Gastric Residual Volume in Fasting Obese Patients Using Gastric Ultrasound: a Comparative Study

Fayoum University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
measurement of gastric residual volume in semi-sitting position

研究概览

简要总结

Gastric emptying is a major risk factor for aspiration of gastric contents.Aspiration into the lungs represents a fatal complication that can occur during anesthesia.

Not only gastric emptying importance to anesthetists is related to aspiration but also it is important to determine the systemic availability of substances given through the mouth. Delayed gastric emptying represents a major danger as it causes nausea and vomiting and prevents a return to oral feeding. Lastly it may cause morbidity and mortality.

Both humoral and neural influences have their impact on emptying. Volume and composition of gastric food act as major determinants for the rate of gastric emptying. The effect of body weight on gastric emptying are inconsistent.

ASA fasting guidelines application represents the primary method to avoid aspiration as it ensures that stomach is empty before induction of anesthesia.

These guidelines cannot be applied on all cases as in urgent or emergent situations or in morbidities associated with delayed gastric emptying.

Ultrasound can be used perioperatively to asses gastric content and volume at bedside.

详细描述

The objective of the current study is to evaluate gastric residual volume in obese patients versus healthy controls scheduled for elective surgery, using gastric ultrasound.

This prospective observational study was performed on 100 patients undergoing elective surgery from July 2019 to June 2020 at Fayoum University hospital after approval of the local institutional ethical committee (M420). A detailed informed consent was signed by the eligible participants before enrollment.

Our study adheres to the CONSORT guidelines. The study was conducted on 100 Patients were assigned to one of two groups of (50) patients in each group. Group obese ASA II from( 30-40) BMI, ASA III above 40 BMI without other comorbidities and group non obese ASA I control.Obese patients whose BMI >30 and healthy patients whose BMI = 18-24.9 who was scheduled for an elective surgery were included in this trial. All patients were enrolled in the study aged above >20 y. This study included patients scheduled for elective surgery after 8-hour overnight fast after a light meal.

Ultrasound scanning:

Focused gastric ultrasound by was performed by a trained physician in semi-sitting position then right lateral position using low frequency (2-5MHz) mindray curved transducer and mindray DP-20 ultrasound system. The antrum of the stomach was located in the epigastrium after a sweep of the probe from left to right subcostal margins. This could be done using left lobe of liver as an anterior landmark and descending abdominal aorta as a posterior landmark.

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
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged from 20 years to 60 years
  • Patients scheduled for elective surgery after an 8-hour overnight fast after a light meal (200 ml milk, 50 g white cheese, and 120 g bread).
  • American society of anesthesiologists physical status I-III.

排除标准

  • Pregnancy
  • Renal failure
  • Liver cell failure
  • History of upper GIT morbidity (hiatus hernia and gastric cancer)
  • History of upper abdominal surgery.

结局指标

主要结局

measurement of gastric residual volume in semi-sitting position

时间窗: 5 minutes preoperatively

in cubic centimetre

次要结局

  • Antral cross sectional area in semi-sitting position(5 minutes preoperatively)
  • volume of fluid aspirated from nasogastric tube(1 minute after induction of anesthesia)
  • Antral cross sectional area in right lateral position(5 minutes preoperatively)
  • grade of aspiration risk(5 minutes preoperatively)
  • Grading for assessment of antrum of the stomach(5 minutes preoperatively)
  • measurement of gastric residual volume in right lateral position.(5 minutes preoperatively)

研究者

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

Atef Mohamed Sayed mahmoud

Principal investigator

Fayoum University Hospital

研究点 (1)

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