6/28/23, 12:08 AM AMBROISIE Pathway Feedback Search Clinical Topics Home Studies AMBROISIE AMBROISIE Trial question Is continued enteral nutrition until extubation noninferior to fasting before extubation in patients in the ICU? Study design Multi-center Open label RCT Population 1130 patients Inclusion criteria: adult patients in receipt of invasive mechanical ventilation for 48 hours in the ICU and prepyloric enteral nutrition for 24 hours at the time of extubation decision Key exclusion criteria: pregnancy; tracheostomy; post-pyloric enterally fed; no affiliation to a social security scheme Interventions N=617 maintenance of calorie intake (continued enteral nutrition until extubation) N=513 maximum gastric vacuity (stopping enteral feeding at least 6 hours before extubation with concomitant gastric suctioning) Primary outcome Rate of extubation failure within 7 days after extubation 17.5 % 17.5 17.2 13.1 % 8.8 % Difference not exceeding nonferiority margin 4.4 % 0.0 % Maintenance of calorie intake Maximum gastric vacuity Difference not exceeding nonferiority margin in the rate of extubation failure within 7 days after extubation (17.2% vs. 17.5%; ARD 0.4, 95% CI -5.2 to 4.5) Secondary outcomes https://web.pathway.md/studies/rec6QKU1FMJcg8zVm 1/2 6/28/23, 12:08 AM AMBROISIE Pathway No significant difference in the rate of pneumonia within 14 days of extubation (1.6% vs. 2.5%; RR 0.77, 95% CI 0.22 to 2.69) Borderline significant decrease in death in the ICU (3.9% vs. 6.8%; RR 0.56, 95% CI 0.32 to 0.99) Borderline significant increase in tachypnea (59% vs. 54%; RR 1.41, 95% CI 1.05 to 1.89) Conclusion In adult patients in receipt of invasive mechanical ventilation for 48 hours in the ICU and prepyloric enteral nutrition for 24 hours at the time of extubation decision, maintenance of calorie intake was noninferior to maximum gastric vacuity with respect to the rate of extubation failure within 7 days after extubation. Reference Micka l Landais, Mai-Anh Nay, Johann Auchabie et al. Continued enteral nutrition until extubation compared with fasting before extubation in patients in the intensive care unit: an open-label, cluster- randomised, parallel-group, non-inferiority trial. Lancet Respir Med. 2023 Apr;11(4):319-328. Open reference URL https://web.pathway.md/studies/rec6QKU1FMJcg8zVm 2/2