A Trial of Bedside Placement of Nasal Jejunal Tube Confirmed by Ultrasound Compared to Placement by Endoscope in Patients With SAP (SAP)
Study to Compare the Placement Method of Nasal Jejunal Tube in Patients With Severe Acute Pancreatitis: Bedside Placement With Ultrasound Confirmation Versus Placement Endoscopically
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.
研究概览
地位
详细说明
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.
研究类型
注册 (预期的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
Jiangsu
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Nanjing、Jiangsu、中国、210002
- 招聘中
- Jinling Hospital
-
接触：
- ke lu, Ph.D
- 邮箱：kkb9832@gmail.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：ultrasound group
using B ultrasound as a instruction technique to place Nasal Jejunal Tube
|
bedside placing nasal jejunal tube with ultrasound confirmation versus placing endoscopically
|
|
安慰剂比较：endoscope group
Conventional methods for placing Nasal Jejunal Tube
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Success rate
大体时间：24 hours
|
Success rate is defined as the right position of nasal jejunal tube confirmed by X-ray.
|
24 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Adverse effects
大体时间：24 hours
|
gastrointestinal perforation, gastrointestinal bleeding, tie of the tube, blocking of the tube
|
24 hours
|
|
Change of intra-abdominal pressure
大体时间：3 days
|
the intra-abdominal pressure at 1h before, 1h after and 3 days after placement
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3 days
|
|
Tolerance of enteral nutrition
大体时间：3 days
|
nausea, vomiting, diarrhea, abdominal pain
|
3 days
|
|
Time interval to approach the target calories
大体时间：7 days
|
The exact time interval from the placement of the tube to the time that the patient can tolerate the target enteral nutrition.
|
7 days
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 110-92
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