Transcutaneous Auricular Stimulation Targeting Enteral Feeding Intolerance

NCT07854236 | Not Yet Recruiting

• 1 other identifier: zjc202605
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Enteral Feeding Intolerance; ICU

Outcome Measures

Primary Outcomes (1)

• Enteral Feeding Intolerance Response Rate

  Percentage of participants who achieve an enteral energy intake of at least 20 kcal/kg/day for at least 48 consecutive hours within the assessment window, without interruption of enteral feeding due to intolerance.

  24-120 hours after enrollment

Secondary Outcomes (22)

• Change in Serum Citrulline Concentration

  Within 24 hours before enrollment and 24-120 hours after enrollment.

• Change in Gut Microbial Diversity Measured by the Shannon Index

  Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.

• Change in Gut Microbial Richness Measured by the Chao1 Index

  Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.

• Changes in Gut Microbial Community Composition

  Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.

• Changes in Relative Abundance of Gut Microbial Taxa

  Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.

Study Arms (2)

Control group

NO INTERVENTION

taVNS intervention group

EXPERIMENTAL

Device: Transcutaneous auricular vagus nerve stimulation

Interventions

Transcutaneous auricular vagus nerve stimulation DEVICE

Transcutaneous auricular vagus nerve stimulation will be delivered through surface electrodes over the cymba conchae and cavum conchae, preferably of the left ear, alongside standard ICU care. Stimulation parameters are 25 Hz, a pulse width of 200-500 microseconds, and an individually adjusted current, typically 0.5-2.0 mA. Sessions will last 60 minutes once daily for five consecutive days. Heart rate, blood pressure, and local skin reactions will be monitored. Stimulation will stop for intolerance or safety concerns and end early upon ICU discharge.

taVNS intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years;
• Admission to the intensive care unit (ICU), with an expected ICU stay of at least 5 days;
• Enteral nutrition has been initiated or is planned;
• Enteral feeding intolerance confirmed during a 72-hour trial of enteral nutrition guided by the study's feeding intolerance assessment: failure to achieve an enteral energy intake of 20 kcal/kg/day within 72 hours, or discontinuation of enteral nutrition for a clinical reason, such as vomiting, diarrhea, gastrointestinal bleeding, or an intestinal fistula. Temporary interruptions for clinical procedures do not qualify;
• Written informed consent provided by the participant or a legally authorized representative.

You may not qualify if:

• An absolute contraindication to enteral nutrition, including but not limited to intestinal ischemia, gastrointestinal perforation, complete bowel obstruction, or active major gastrointestinal bleeding;
• Severe cardiac arrhythmia or high-grade atrioventricular block;
• An implanted cardiac pacemaker, implantable cardioverter-defibrillator, or other implanted electronic device;
• Local infection, ulceration, skin injury, or another condition affecting the outer ear that makes transcutaneous auricular vagus nerve stimulation unsuitable;
• Pregnancy or breastfeeding;
• Expected death within 24 hours or receipt of end-of-life care.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 8, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-10

Locations

CN (1)