Stephen J Taylor1, Kaylee Allan2, Helen McWilliam3, Alex Manara4, Jules Brown5, Rosemary Greenwood6, Deirdre Toher7. 1. Department of Nutrition and Dietetics, Level 6, Gate 10, Brunel Building, Southmead Hospital, Bristol, BS105 NB, UK. Electronic address: stephen.taylor@nbt.nhs.uk. 2. Department of Nutrition and Dietetics, Level 6, Gate 10, Brunel Building, Southmead Hospital, Bristol, BS105 NB, UK. Electronic address: kaylee.allan@nbt.nhs.uk. 3. Department of Nutrition and Dietetics, Level 6, Gate 10, Brunel Building, Southmead Hospital, Bristol, BS105 NB, UK. Electronic address: Helen.McWilliam@nuth.nhs.uk. 4. Department of Anaesthetics, Level 3 Gate 38, Brunel Building, Southmead Hospital, Bristol, BS10 5NB, UK. Electronic address: alex.manara@nbt.nhs.uk. 5. Department of Anaesthetics, Level 3 Gate 38, Brunel Building, Southmead Hospital, Bristol, BS10 5NB, UK. Electronic address: jules.brown@nbt.nhs.uk. 6. Research Design Service - South West, University Hospitals Bristol NHS Foundation Trust, Level 3 Education Centre, Upper Maudlin Street, Bristol, BS2 8AE, UK. Electronic address: rosemary.greenwood@UHBristol.nhs.uk. 7. Department of Engineering Design and Mathematics, University of the West of England, Frenchay Campus, Bristol, BS16 1QY, UK. Electronic address: Deirdre.toher@uwe.ac.uk.
Abstract
BACKGROUND & AIMS:Delayed gastric emptying (DGE) commonly limits the use of enteral nutrition (EN) and may increase ventilator-associated pneumonia. Nasointestinal feeding has not been tested against dual prokinetic treatment (Metoclopramide and Erythromycin) in DGE refractory to metoclopramide. This trial tests the feasibility of recruiting this 'treatment-failed' population and the proof of concept that nasointestinal (NI) feeding can increase the amount of feed tolerated (% goal) when compared to nasogastric (NG) feeding plus metoclopramide and erythromycin treatment. METHODS:Eligible patients were those who were mechanically ventilated and over 20 years old, with delayed gastric emptying (DGE), defined as a gastric residual volume ≥250 ml or vomiting, and who failed to respond to first-line prokinetic treatment of 3 doses of 10 mg IVmetoclopramide over 24 h. When assent was obtained, patients were randomised to receive immediate nasointestinal tube placement and feeding or nasogastric feeding plus metoclopramide and erythromycin (prokinetic) treatment. RESULTS: Of 208 patients with DGE, 77 were eligible, 2 refused assent, 25 had contraindications to intervention, almost exclusively prokinetic treatment, and it was feasible to recruit 50. Compared to patients receiving prokinetics (n = 25) those randomised to nasointestinal feeding (n = 25) tolerated more of their feed goal over 5 days (87-95% vs 50-89%) and had a greater area under the curve (median [IQR] 432 [253-464]% vs 350 [213-381]%, p = 0.026) demonstrating proof of concept. However, nasointestinally fed patients also had a larger gastric loss (not feed) associated with the NI route but not with the fluid volume or energy delivered. CONCLUSIONS: This is first study showing that in DGE refractory to metoclopramide NI feeding can increase the feed goal tolerated when compared to dual prokinetic treatment. Future studies should investigate the effect on clinical outcomes. EU CLINICAL TRIALS REGISTER: EudraCT number: 2012-001374-29.
RCT Entities:
BACKGROUND & AIMS: Delayed gastric emptying (DGE) commonly limits the use of enteral nutrition (EN) and may increase ventilator-associated pneumonia. Nasointestinal feeding has not been tested against dual prokinetic treatment (Metoclopramide and Erythromycin) in DGE refractory to metoclopramide. This trial tests the feasibility of recruiting this 'treatment-failed' population and the proof of concept that nasointestinal (NI) feeding can increase the amount of feed tolerated (% goal) when compared to nasogastric (NG) feeding plus metoclopramide and erythromycin treatment. METHODS: Eligible patients were those who were mechanically ventilated and over 20 years old, with delayed gastric emptying (DGE), defined as a gastric residual volume ≥250 ml or vomiting, and who failed to respond to first-line prokinetic treatment of 3 doses of 10 mg IV metoclopramide over 24 h. When assent was obtained, patients were randomised to receive immediate nasointestinal tube placement and feeding or nasogastric feeding plus metoclopramide and erythromycin (prokinetic) treatment. RESULTS: Of 208 patients with DGE, 77 were eligible, 2 refused assent, 25 had contraindications to intervention, almost exclusively prokinetic treatment, and it was feasible to recruit 50. Compared to patients receiving prokinetics (n = 25) those randomised to nasointestinal feeding (n = 25) tolerated more of their feed goal over 5 days (87-95% vs 50-89%) and had a greater area under the curve (median [IQR] 432 [253-464]% vs 350 [213-381]%, p = 0.026) demonstrating proof of concept. However, nasointestinally fed patients also had a larger gastric loss (not feed) associated with the NI route but not with the fluid volume or energy delivered. CONCLUSIONS: This is first study showing that in DGE refractory to metoclopramide NI feeding can increase the feed goal tolerated when compared to dual prokinetic treatment. Future studies should investigate the effect on clinical outcomes. EU CLINICAL TRIALS REGISTER: EudraCT number: 2012-001374-29.