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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210002
- Rekruttering
- Jinling Hospital
-
Kontakt:
- ke lu, Ph.D
- E-mail: kkb9832@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
|
Placebo komparator: endoscope group
Conventional methods for placing Nasal Jejunal Tube
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Success rate
Tidsramme: 24 hours
|
Success rate is defined as the right position of nasal jejunal tube confirmed by X-ray.
|
24 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Adverse effects
Tidsramme: 24 hours
|
gastrointestinal perforation, gastrointestinal bleeding, tie of the tube, blocking of the tube
|
24 hours
|
|
Change of intra-abdominal pressure
Tidsramme: 3 days
|
the intra-abdominal pressure at 1h before, 1h after and 3 days after placement
|
3 days
|
|
Tolerance of enteral nutrition
Tidsramme: 3 days
|
nausea, vomiting, diarrhea, abdominal pain
|
3 days
|
|
Time interval to approach the target calories
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 110-92
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