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临床试验/NCT02983175
NCT02983175Unknown不适用

Ultrasound Assessment of Gastric Content and Gastric Volume Before Crash Induction for Appendectomy

Central Hospital, Nancy, France0 个研究点目标入组 150 人开始时间: 2016年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
150
主要终点
Cross-section antral area (CSA)

研究概览

简要总结

Performing anesthetic induction for appendicectomy has two main risks : first aspiraion of gastric content causing pneumonia. Otherwise, anaphylactic risk to drugs used during anesthetic induction. Indeed, the guidelines recommend an anesthetic induction protocol qualified "full stomach" whatever the patient and the preoperative fasting period are. This protocol provides the use of fast-acting neuromuscular blocking agents (succinylcholine or rocuronium). However, these neuromuscular blocking agents are ten times more at allergic risk than others. Ultrasound assessment of gastric content before rapid sequence induction of anesthesia is a reproducible, non-invasive, inexpensive and quickly achievable bedside technique. Furthermore, the correlations between gastric volume and risk of a full stomach and also between the cross-section antral area (CSA) and the risk of a full stomach have been validated on several patient cohorts. We formulate the hypothesis that the achievement of a gastric ultrasound before anesthetic induction for appendectomy could allow to identify "full stomach" patients who actually justify rapid sequence induction of anesthesia with exposure to fast-acting neuromuscular blocking agents that implies.

Primary endpoint is to determine te percentage of patients who have a gastric content before appendectomy. Secondary endpoint is to determine the incidenc of aspiration pneumonia and anaphylactic shock. Another secondary endpoint is to determine the percentage of patient with gastric content with the antral grading system (Perlas method) and to evaluate the concordance between this methode and the cross-section antral area.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient admitted to the operating room for appendectomy.
  • •Major or minor patient (higher than 16) affiliated to a social security scheme.
  • •Patient or parents of minor patient who received the full information relative to the organization of the study and who signed his/their informed consent(s).

排除标准

  • •Pregnant women.
  • •Childbearing age patient does not have effective contraception.
  • •Breastfeeding woman.
  • •Minor patient under
  • •Major patient subject to a measure of legal protection or unable to consent.
  • •Persons deprived of liberty by a judicial or an administrative decision.
  • •Patient with gastric and/or esophagus surgery history.

研究组 & 干预措施

ultrasound assessment of gastric content

Experimental

干预措施: ultrasound assessment of gastric content (Other)

结局指标

主要结局

Cross-section antral area (CSA)

时间窗: baseline J0

Ultrasonography exam of the stomach is used to evaluate the CSA. A CSA greater than 340mm² defines a full stomach. The calculation of the CSA is : CSA = AP x CC x π / 4 (in mm²). With AP - antero-posterior gastric antrum diameter and CC - cranio-caudal gastric antrum diameter

次要结局

未报告次要终点

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

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