The use of continued enteral nutrition prior to extubation is noninferior to a 6-hour fasting gastric vacuity strategy in patients in the intensive care unit (ICU), according to study findings published in The Lancet Respiratory Medicine.
Although fasting is often imposed on patients in the ICU prior to extubation, with the intent of reducing patients’ risk for aspiration, this practice has yet to be fully evaluated. Investigators therefore sought to assess whether this practice might actually delay extubation, increase workload, and reduce caloric intake.
The researchers conducted a pragmatic, open-label, cluster-randomized, parallel-group trial (ClinicalTrials.gov Identifier: NCT03335345) at 22 ICUs in France that compared continuing enteral nutrition of patients in the ICU up until extubation vs imposing fasting upon these patients prior to extubation. The trial involved adults who had received invasive mechanical ventilation for at least 48 hours in the ICU and had received prepyloric enteral nutrition for at least 24 hours at the time of the decision to extubate. All of the participating centers were randomly assigned in a 1:1 ratio to either continue enteral nutrition until extubation or to impose 6-hour fasting with concomitant gastric suctioning prior to extubation.
The primary study outcome was extubation failure (ie, a composite of reintubation or death) within 7 days following extubation, which was evaluated in both the intention-to-treat (ITT) and the per-protocol populations. The margin for noninferiority was set at 10%. A key secondary endpoint was pneumonia within 14 days of extubation.
Between April 1, 2018, and October 31, 2019, a total of 7056 individuals who received enteral nutrition and mechanical ventilation were admitted to the 22 ICUs, with 4198 of them evaluated for eligibility. Ultimately, 1130 patients were enrolled and included in the ITT population and 1008 were included in the per-protocol population. Baseline characteristics were similar among patients in the 2 cohorts compared (ie, those assigned to receive enteral nutrition until extubation and those assigned to fasting).
Findings from the study showed that in the ITT population, extubation failure was reported in 17.2% (106 of 617) of patients assigned to receive continued enteral nutrition until extubation vs 17.5% (90 of 513) of those assigned to fasting, thus fulfilling the a priori defined noninferiority criterion (absolute difference [AD], –0.4%; 95% CI, -5.2 to 4.5).
In the per-protocol population, extubation failure was reported in 17.0% (101 of 595) of patients assigned to receive continued enteral nutrition until extubation vs 17.9% (74 of 413) of those assigned to fasting (AD, -0.9%; 95% CI, -5.6 to 3.7).
The occurrence of pneumonia within 14 days was reported in 1.6% (10 of 617) of participants assigned to receive continued enteral nutrition vs 2.5% (13 of 513) of those assigned to fasting (rate ratio, 0.77; 95% CI, 0.22 to 2.69).
With respect to other exploratory outcomes, the researchers found that:
- death in the ICU occurred significantly less frequently in the continued enteral nutrition group vs the fasting group (3.9% vs 6.8% of patients, respectively; rate ratio, 0.56; 95% CI, 0.32-099);
- the median duration from the first successful breathing trial to both extubation and discharge from the ICU was shorter among those receiving continued enteral nutrition;
- tachypnoea within 7 days post extubation occurred more frequently in the continued enteral nutrition group;
- the extubation failure rates at both 48 hours and 72 hours were higher in the continued enteral nutrition group; and
- occurrences of hypoglycaemia before extubation on the day of extubation and hyperglycaemia on the day before extubation were significantly less frequent in the continued enteral nutrition group.
Several limitations of this analysis should be noted. The study was not blinded because of the nature of the intervention and the pragmatic design with cluster randomization at the level of the ICU. The primary composite outcome of extubation failure was influenced, in part, by physicians’ decisions to intubate patients. Additionally, the open-label, cluster-randomized design of the study might not fully control for all potential confounding factors and recruitment bias.
The authors concluded, “The non-inferiority of continued enteral nutrition until extubation, in terms of extubation failure within 7 days (a patient-centered outcome), supports change in clinical practice towards this safe alternative.”
Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Landais M, Nay M-A, Auchabie J, et al; REVA network and CRICS-TriggerSEP F-CRIN research network. 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 online January 20, 2023. doi:10.1016/S2213-2600(22)00413-1