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
Primary result · Extubation failure (ITT)Result — go to the resultAbsolute difference −0.4% 95% CI −5.2 to 4.5Authors' conclusion
Continued enteral nutrition until extubation in critically ill patients in the intensive care unit was non-inferior to a 6-h fasting maximum gastric vacuity strategy comprising continuous gastric tube suctioning, in terms of extubation failure within 7 days (a patient-centred outcome), and thus represents a potential alternative in this population.
Study context
- Population
- Adults in 22 French ICUs on invasive mechanical ventilation ≥48 h receiving prepyloric enteral nutrition ≥24 h at extubation decision1,008 per-protocol
- Participants
- 1,130 adults
- Comparison
- Continued enteral nutrition vs Fasting
- Continued enteral nutritionn = 617
- Fastingn = 513reference
- Primary endpoint
- Extubation failure:
- Reintubation
- Death
- Follow-up
- Within 7 days after extubation
Methodological detailsopen-label, cluster-randomised, parallel-group, non-inferiority, multicentre
- Open-label
- Cluster-randomised
- Parallel-group
- Non-inferiority
- Multicentre
Primary result
Extubation failure (ITT) · 7 days
Absolute difference
−0.4%
95% CI −5.2 to 4.5
Events by treatment group
Continued enteral nutrition vs Fasting
absolute difference −0.4% (95% CI −5.2 to 4.5)
Non-inferiority margin 10 as printed, not drawn
As reported in the abstract
Secondary outcomes
| Outcome | Continued enteral nutrition | Fasting | Absolute difference (95% CI) | |
|---|---|---|---|---|
| Extubation failure (per-protocol) · 7 daysPer-protocol | 17.0% | 17.9% | −0.9% (−5.6 to 3.7) | |
| −10−505Difference (linear scale) |
Safety
| Outcome | Continued enteral nutrition | Fasting | Rate ratio (95% CI) | |
|---|---|---|---|---|
| Pneumonia (key secondary endpoint) · within 14 days of extubation | 1.6% | 2.5% | 0.77 (0.22–2.69) | |
| 0.20.5125Rate ratio (log scale) |
Original publication
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. Published 21 January 2023. doi:10.
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