Efficacy of Nasojejunal Enteral Feeding in Critically Ill Patients.
The purpose of this study is to determine if naso-jejunal feeding (feeding beyond the stomach) improves the efficacy of enteral feeding (feeding into the gut) in critically ill patients.
The study hypothesis is that in patients who fail to establish enteral feeding via the nasogastric route, introduction of nasojejunal feeding will lead to more effective enteral feeding than the current regime involving staged introduction of promotility agents.
Studieoversigt
Detaljeret beskrivelse
The study examines the area of enteral feeding in critically ill patients. Current standard enteral feeding practice is via a nasogastric with the addition of promotility agents for patients who fail to absorb their enteral nutrition.
This study compares the efficacy of nasojejunal feeding feeding with nasogastric enteral feeding with the addition of promotility agents.
The duration of feeding will be determined by the patients nutritional requirements and their general condition. However the data will be collected for duration of enteral feeding, 28 days or ICU discharge whichever occurs first.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Victoria
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Parkville, Victoria, Australien, 3050
- Intensive Care Unit, Royal Melbourne Hospital, Grattan Street
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Adult patients (18years or over) admitted to the ICU with an expected stay of more than 48 hours.
- Patients commenced on enteral feeding via a nasogastric tube who fail to tolerate gastric feeding due to excessive gastric aspirate volumes.
Patients who consent or if the patient is incompetent, the next of kin, who consent, to inclusion in the study.
-
Exclusion Criteria:
- patients less than 18 years of age.
- Patients with known allergy to promotility agents, metoclopramide or erythromycin.
- Patients with a contra indication to nasojejunal feeding. -
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 |
|---|---|
|
Ingen indgriben: Standard Care
Patients will receive enteral nutrition via a nasogastric tube as per standard feeding regime
|
|
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Aktiv komparator: Nasojejunal Arm
Patient will receive feeding via a nasojejunal feeding tube
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Efficacy of feeding
Tidsramme: participants will be followed until death, discharge from ICU, commencement of oral or parental nutrition or 28 days post ICU admission
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participants will be followed until death, discharge from ICU, commencement of oral or parental nutrition or 28 days post ICU admission
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
1. To determine the incidence of complications with enteral feeding via nasogastric and nasojejunal routes.
Tidsramme: participants will be followed until death, discharge from ICU, commencement of parental or oral nutrition or 28 days post ICU admission.
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participants will be followed until death, discharge from ICU, commencement of parental or oral nutrition or 28 days post ICU admission.
|
|
2. To assess the efficacy of current strategies for optimising enteral feeding efficacy.
Tidsramme: participants will be followed until death, discharge from ICU commencement of oral or parental nutrition,or 28 days post ICU admission.
|
participants will be followed until death, discharge from ICU commencement of oral or parental nutrition,or 28 days post ICU admission.
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Megan Robertson, Intensive Care Unit, Royal Melbourne Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2002.228
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