CONTINUE
CONTINUation of Enteral nutrition prior to extubation compared to standard care: a pilot randomised controlled trial
CONTINUE is a multi-centre, unblinded prospective parallel, pilot randomised control trial in 60 critically ill adult patients. Aims: The primary aim is to determine whether continuing enteral nutrition (EN) to the point of extubation and performing maximal nasogastric aspiration immediately prior is feasible and decreases total fasting in the period prior to extubation compared to standard practice of ceasing EN 4-6 hours prior to planned extubation in low risk ventilated patients. A further aim is the assessment of important safety related endpoints to inform the design of a possible phase III RCT. |  |
Rationale: The provision of EN is standard practice to mechanically ventilated patients within the Intensive Care Unit (ICU). Delivery is frequently interrupted, with patients often receiving approximately half of prescribed volumes. One of the main contributors to this is fasting prior to extubation. Fasting prior to extubation is historically informed from pre-anaesthetic practice in patients who are not critically ill where fasting allows for adequate gastric emptying and reduces the risk of aspiration on induction. The practice of fasting prior to extubation in the ICU is variable and there is no evidence-based consensus as to the rationale and duration of fasting critically ill patients prior to extubation.
Study Progress: Primary recruitment is completed with data analysis to commence before the end of 2025.
Registration: ClinicalTrials.gov NCT06382727
Funding: This study is unfunded.
Co-enrolment: Co-enrolment in any other interventional study will be considered on a case-by-case basis.