๐ฌIn plain words
What the trial is, and whether it could suit you
This study will compare two commonly used methods of enteral feeding in critically ill adults: continuous feeding and intermittent feeding. The main purpose is to determine whether the amount of feeding fluid remaining in the stomach differs between the two methods.
A total of 76 participants will be randomly assigned to receive either continuous gastric feeding or intermittent gastric feeding every 4 hours. Gastric ultrasound will be performed at the bedside before starting the assigned feeding method and then every 4 hours for 72 hours. The study will also record symptoms of feeding intolerance, such as vomiting, regurgitation, abdominal distension, diarrhea, constipation, feeding interruptions, and the amount of prescribed nutrition actually delivered.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โฅ0.3 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.
HealthTeky