Continuing enteral nutrition before removing breathing tubes in critically ill patients
CONTINUation of Enteral Nutrition Prior to Extubation Compared to Standard Care: a Pilot Randomised Controlled Trial (CONTINUE Trial)
This study is testing if keeping critically ill patients on feeding tubes right up until they have their breathing tubes removed can help them recover better than stopping their feedings beforehand.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Alfred Academic / other |
| Locations | 3 sites (Southport, Queensland and 2 other locations) |
| Trial ID | NCT06382727 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of continuing enteral nutrition (EN) in critically ill patients who are on mechanical ventilation and are planned for extubation. Traditionally, EN is paused before extubation based on practices from non-ICU settings, but this study aims to determine if continuing EN until extubation is safe and beneficial. The research will compare outcomes between patients who continue receiving EN and those who undergo standard care with fasting. The goal is to address the evidence gap regarding fasting practices in ICU patients and improve nutritional delivery during critical illness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are receiving invasive mechanical ventilation for more than 24 hours but less than 10 days and are planned for extubation during daytime hours.
Not a fit: Patients who have specific contraindications such as recent laparotomy, significant gastric residuals, or those requiring critical medications via enteral routes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance nutritional support for critically ill patients, potentially improving recovery times and overall outcomes.
How similar studies have performed: While there is limited evidence on this specific approach, previous studies have highlighted the variability and lack of consensus on fasting practices in ICU settings, indicating a need for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * Receiving invasive mechanical ventilation \> 24 hours and \< 10 days in the index ICU admission * Receiving EN at a rate ≥ 30ml/hr * Planned for extubation within the hours of 0800-1800 Exclusion Criteria: * EN delivery via a fine bore nasogastric tube that is unable to be aspirated * A single gastric residual volume ≥ the maximum protocol limit at the participating site has been recorded within the last 24 hours * Currently receiving extracorporeal membrane oxygenation * Acute neurological pathology * A time critical medication is required via the enteral route (including anti-parkinsons and immunosuppressant medication) and no adjustments can be made * Pre-existing swallow, bulbar dysfunction and/or concern around inadequate airway protection * A laparotomy has been performed within 72 hours of planned extubation * Confirmed pregnancy * Patient not deemed appropriate to be reintubated in the event of deterioration * Treating clinician believes enrolment is not in the best interests of the patient
Where this trial is running
Southport, Queensland and 2 other locations
- Gold Coast University Hospital — Southport, Queensland, Australia (Recruiting)
- St Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia (Recruiting)
- The Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Emma Ridley, A/Prof
- Email: emma.ridley@monash.edu
- Phone: +61 3 9903 0350
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.