CONTINUation of Enteral Nutrition Prior to Extubation Compared to Standard Care (NCT06382727) | Clinical Trial Compass
CompletedNot Applicable
CONTINUation of Enteral Nutrition Prior to Extubation Compared to Standard Care
Australia60 participantsStarted 2024-05-20
Plain-language summary
Critically ill patients admitted to the Intensive Care Unit (ICU) often need to be connected to a breathing machine (ventilator) and are unable to eat. During this time, liquid nutrition is delivered via a feeding tube to the stomach or bowel (termed enteral nutrition (EN)) to ensure nutrition needs are provided until such time that the patient can eat normally.
The delivery of nutrition via EN is frequently interrupted due to procedures and changes in the gastrointestinal system that can cause digestion to be slow. One of the main contributors to EN interruptions is fasting prior to removal of the breathing tube (termed extubation).
The practice of pausing EN prior to the removal of the breathing tube is historical and based on evidence for patients who are not within the ICU. There is currently no scientific consensus on whether pausing of EN is necessary, or for how long. Because of this, some clinicians choose to pause EN prior to removal of the breathing tube and some clinicians continue to provide EN.
This study is a pilot randomised controlled trial of fasting patients for at least 4 hours prior to removal of the breathing tube compared with not pausing EN. The investigators hypothesise that this will reduce the number of hours of fasting in the 24 hours prior to extubation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fasting time (hours)
Timeframe: 24 hours prior to endotracheal tube removal