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.
Studieoversikt
Status
Detaljert 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.
Studietype
Registrering (Forventet)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Jiangsu
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Nanjing, Jiangsu, Kina, 210002
- Rekruttering
- Jinling Hospital
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Ta kontakt med:
- ke lu, Ph.D
- E-post: kkb9832@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: ultrasound group
using B ultrasound as a instruction technique to place Nasal Jejunal Tube
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bedside placing nasal jejunal tube with ultrasound confirmation versus placing endoscopically
|
|
Placebo komparator: endoscope group
Conventional methods for placing Nasal Jejunal Tube
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Success rate
Tidsramme: 24 hours
|
Success rate is defined as the right position of nasal jejunal tube confirmed by X-ray.
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24 hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Adverse effects
Tidsramme: 24 hours
|
gastrointestinal perforation, gastrointestinal bleeding, tie of the tube, blocking of the tube
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24 hours
|
|
Change of intra-abdominal pressure
Tidsramme: 3 days
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the intra-abdominal pressure at 1h before, 1h after and 3 days after placement
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3 days
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Tolerance of enteral nutrition
Tidsramme: 3 days
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nausea, vomiting, diarrhea, abdominal pain
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3 days
|
|
Time interval to approach the target calories
Tidsramme: 7 days
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The exact time interval from the placement of the tube to the time that the patient can tolerate the target enteral nutrition.
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7 days
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 110-92
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