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临床试验/NCT05181904
NCT05181904终止不适用

Gastric Content Ultrasound Monitoring Prior to Extubation in Critically Ill Children

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
34
试验地点
1
主要终点
Percentage of critically ill children presenting with a full stomach 6 hours after enteral feeding interruption for planned extubation

研究概览

简要总结

Nearly half of critically ill children are intubated and enterally fed according to recent guidelines. However, no evidence-based recommendation are available regarding fasting times prior to extubation.

When an extubation is planned, children do not always present with normal neurological status yet, and are at risk of vomiting and aspiration. Extubation may also fail and require re-intubation with similar risks. Thus, pre-operative fasting guidelines are often transposed to the paediatric critical care setting, aiming for an empty stomach at extubation, with perceived decreased risks of aspiration. However, the gastric and gut motility pathophysiology is significantly different in critically ill children (frequent gastroparesis, liquid continuous feeding, etc.) compared to planned surgery children. The extrapolation of practice validated in the latter population may be inadequate. The stomach may be empty more or less rapidly than expected, leading to unnecessary prolonged fasting times or inappropriately short fasting times respectively.

Gastric ultrasounding monitoring may help assessing gastric content prior to extubation.

Investigators hypothesise gastric content clearance may be different in critically ill children prior to extubation, compared to pre-operative paediatric guidelines for elective surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 0 to 17 year old children admitted to pediatric intensive care unit
  • intubated (oral or nasal tracheal tube)
  • gastric enteral feeding affording at least 25% of the nutritional target (estimated with Schofield equations)
  • No opposition from one of the 2 parents (or legal representatives)

排除标准

  • anatomical anomaly of the stomach location (e.g. post surgery)
  • Difficult access to perform gastric ultra-sounding (drains, plasters, dressings etc.)
  • mobilization to right lateral decubitus at risk

结局指标

主要结局

Percentage of critically ill children presenting with a full stomach 6 hours after enteral feeding interruption for planned extubation

时间窗: 12 hours following the inclusion

Percentage of critically ill children presenting with a full stomach (according to PERLAS criteria) 6 hours after enteral feeding interruption for planned extubation. Gastric emptiness is assessed with gastric ultrasounding, depicting gastric content (empty versus full). Antral diameter will also be measured and gastric volume will be calculated to allow classifying gastric content according to PERLAS criteria.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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