Bedside Placement of Nasal Jejunal Tube
Conditions
Keywords
bedside placement, nasal jejunal tube, ultrasound, severe acute pancreatitis, endoscope, efficacy, safety
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREplacing nasal jejunal tube with ultrasound
bedside placing nasal jejunal tube with ultrasound confirmation versus placing endoscopically
PROCEDUREplacing nasal jejunal tube endoscopically
Sponsors
Li Gang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate | 24 hours | Success rate is defined as the right position of nasal jejunal tube confirmed by X-ray. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects | 24 hours | gastrointestinal perforation, gastrointestinal bleeding, tie of the tube, blocking of the tube |
| Change of intra-abdominal pressure | 3 days | the intra-abdominal pressure at 1h before, 1h after and 3 days after placement |
| Tolerance of enteral nutrition | 3 days | nausea, vomiting, diarrhea, abdominal pain |
| Time interval to approach the target calories | 7 days | The exact time interval from the placement of the tube to the time that the patient can tolerate the target enteral nutrition. |
Countries
China
Contacts
Primary ContactGang Li, MD.
Outcome results
None listed