NCT07312890招募中不适用
Bedside Observation by Clinical Ultrasound for Stomach Expansion
Centre Hospitalier Saint Joseph Saint Luc de Lyon2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年10月25日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Enteral nutrition intolerance
研究概览
简要总结
The objective of the BOCUSE study is to demonstrate a relationship between an early ultrasound measurement of the gastric antral area and the subsequent occurrence of poor gastric tolerance.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Predicted mechanical ventilation ≥ 48 hours
- •Initiation of enteral nutrition via nasogastric or orogastric tube for ≥ 48 hours
- •Free and informed consent obtained from the patient's relative or legal representative, or inclusion in an emergency situation
排除标准
- •History of major gastric surgery (bypass, total gastrectomy, biliopancreatic diversion)
- •Enteral nutrition via nasogastric or orogastric tube > 96 hours
- •Initiation of enteral nutrition before intubation
- •Feeding via gastrostomy, jejunostomy, or jejunal tube
- •Pregnancy
- •Prognosis considered terminal
- •No ultrasound window available
- •Legally protected adults (under curatorship, guardianship, or judicial protection)
- •No social security coverage
- •Patient under State Medical Aid (AME)
结局指标
主要结局
Enteral nutrition intolerance
时间窗: Within 7 days following the gastric ultrasound
Presence of regurgitation and/or vomiting and/or interruption or reduction of enteral nutrition flow rates
次要结局
- Occurrence of VAP(From H0 until ICU discharge, up to 3 months)
- Mortality(At ICU discharge, at 28 days, and at 3 months)
- Duration of mechanical ventilation(From H0 until ICU discharge, up to 3 months)
- Number of ventilator-free days(Day 28, 3 months)
- Length of stay in the ICU(From ICU admission until ICU discharge, up to 3 months)
研究者
研究点 (2)
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