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
17.2%
17.5%
17.5 %
13.1 %
8.8 %
4.4 %
0.0 %
Maintenance of calorie
intake
Maximum gastric
vacuity
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority 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
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).
Significant decrease in death in the ICU (3.9% vs. 6.8%; RR 0.56, 95% CI 0.32 to 0.99).
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
Mickaël 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.
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