Transcutaneous Auricular Stimulation Targeting Enteral Feeding Intolerance

Brief Summary

This study will test whether electrical stimulation applied to the outer ear can improve tolerance of tube feeding in critically ill adults in the intensive care unit (ICU). Some ICU patients develop digestive problems, such as vomiting, diarrhea, or a buildup of feeding liquid in the stomach. These problems can prevent them from receiving enough nutrition through a feeding tube. This is called enteral feeding intolerance. The treatment being studied is called transcutaneous auricular vagus nerve stimulation (taVNS). It delivers small electrical pulses through electrodes placed on the skin of the outer ear, usually the left ear. It does not require surgery. The treatment targets a branch of the vagus nerve, which helps regulate digestion. Researchers want to find out whether adding this treatment to usual ICU care improves feeding tolerance and whether it causes side effects. The study will enroll 60 adults aged 18 years or older with enteral feeding intolerance at one hospital. Participants will be assigned by chance to one of two groups, with an equal chance of joining either group: * Usual ICU care alone. * Usual ICU care plus ear stimulation for 60 minutes once daily for five days. Stimulation will stop earlier if a participant leaves the ICU or the study team determines that it should be stopped for safety reasons. The main measure will be the proportion of participants whose feeding intolerance improves between 24 and 120 hours after enrollment. Improvement means receiving the study's target amount of calories through tube feeding for at least 48 consecutive hours without stopping feeding because of intolerance. Researchers will also collect blood samples and rectal swabs to study intestinal function, gut bacteria, and substances produced by the body and gut bacteria. They will record the use of pain medicines and sedatives, changes in illness severity, and possible side effects, including skin irritation, a slow heartbeat, or low blood pressure. Study assessments and sample collection in the ICU will continue for up to seven days after enrollment, ending earlier if the participant leaves the ICU. Follow-up at 28 and 90 days will assess survival and, at 90 days, new infections and hospital readmissions.

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