Study to Compare the Placement Method of Nasal Jejunal Tube in Patients With Severe Acute Pancreatitis: Bedside Placement With Ultrasound Confirmation Versus Placement Endoscopically
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Success rate
研究概览
简要总结
The investigators assessed the utility of ultrasonography in confirming the position of nasal jejunal tube after bedside placement when compared with endoscopic placement in patients with severe acute pancreatitis.
Primary endpoint:
Success rate.
Secondary Endpoint:
Adverse effects, Change of intra-abdominal pressure (1h before, 1h after and 3 days after placement), Tolerance of enteral nutrition, Time to approach the target calories.
详细描述
We set this randomised trial to assess the safety and utility of ultrasonography in confirming the position of nasal jejunal tube after bedside placement when compared with endoscopic placement in patients with severe acute pancreatitis.
Primary endpoint:
Success rate.
Secondary Endpoint:
Adverse effects, Change of intra-abdominal pressure (1h before, 1h after and 3 days after placement), Tolerance of enteral nutrition, Time to approach the target calories.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute pancreatitis patients who need enteral nutrition;
- •patients in acute phase of pancreatitis (within 2 weeks from onset);
- •the severity of pancreatitis is equal to or above moderate (according to the revised classification of pancreatitis).
排除标准
- •diagnosed with IAH(Intra-abdominal pressure) IV grade, abdominal compartment syndrome (ACS);
- •patients who have circulatory failure;
- •patients who have gastrointestinal bleeding;
- •patients who have specific diseases such as chronic digestive diseases and autoimmune diseases;
- •patients in pregnancy.
结局指标
主要结局
Success rate
时间窗: 24 hours
Success rate is defined as the right position of nasal jejunal tube confirmed by X-ray.
次要结局
- Adverse effects(24 hours)
- Change of intra-abdominal pressure(3 days)
- Tolerance of enteral nutrition(3 days)
- Time interval to approach the target calories(7 days)
研究者
Li Gang
Jinling Hospital
Nanjing University