Continuous vs. Intermittent Enteral Feeding in Critically Ill Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this single-center randomized trial, critically ill adults requiring gastric enteral nutrition are assigned to either continuous feeding via a pump or intermittent feeds every 4 hours. Gastric ultrasound will be used at baseline and every 4 hours for 72 hours to estimate gastric residual volume, while monitoring feeding intolerance and delivery of prescribed nutrition. The primary outcome is the mean ultrasound-estimated gastric residual volume from 18 measurements between 4 and 72 hours. Secondary data include symptoms such as vomiting, distension, diarrhea or constipation, feeding interruptions, and use of prokinetics. The trial aims to determine if the method of delivery affects gastric residuals and feeding tolerance in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 to 80 years.
* Currently treated in an intensive care unit and has a clinical indication for gastric enteral nutrition through a nasogastric or orogastric tube.
* The gastrointestinal tract is considered usable for enteral nutrition according to the treating physician.
* Expected to remain in the intensive care unit and to be available for study follow-up for 72 hours after randomization, unless a prespecified early stopping criterion occurs.
* A gastric enteral nutrition plan is in place; the enteral formula and energy/protein targets are determined by the treating physician in consultation with the Department of Nutrition before randomization.
* Written informed consent is provided by the participant or a legally authorized representative.

Exclusion Criteria:

* Previous gastrectomy, pyloric stenosis, or recent gastric or duodenal surgery that alters gastric anatomy or function and may affect ultrasound-based gastric volume estimation.
* Contraindication to enteral nutrition, including bowel obstruction, severe ileus, gastrointestinal perforation, intestinal ischemia or necrosis, severe gastrointestinal bleeding, or another condition requiring complete cessation of enteral feeding.
* Expected death, transfer out of the intensive care unit, or removal of the gastric tube in the near term such that 72-hour study follow-up is not feasible.
* Receiving exclusive parenteral nutrition with no plan to initiate gastric enteral feeding.
* Pregnancy.
* Uncontrolled shock or hemodynamic instability at screening, defined as norepinephrine ≥0.3 micrograms/kg/min or an equivalent vasopressor requirement according to the treating physician.
* Unable to tolerate brief right lateral positioning for gastric ultrasonography because of hemodynamic or respiratory instability, spinal injury or fixation, contraindication to turning, or another safety concern.
* Gastric antrum cannot be adequately visualized at screening because of an inadequate acoustic window, surgical wound or dressing, subcutaneous emphysema, excessive gas, or another reason.
* Participant or legally authorized representative declines participation.
* Participant lacks capacity to provide consent and no legally authorized representative is available at enrollment.

Where it's running

• Viet Duc University Hospital
  Hà Nội, Vietnam Recruiting

Study contacts

• Study coordinator: Thu Phuong Hoang, MD
• Email: hoangthuphuongdb@gmail.com
• Phone: +84 943 671 709

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.