Transcutaneous Auricular Stimulation Targeting Enteral Feeding Intolerance (TASTE-FI)
Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation for Enteral Feeding Intolerance in Critically Ill Patients in the Intensive Care Unit: A Single-Center, Single-Blind, Randomized Controlled Trial
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Wuhan, Čína
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Kontakt:
- Jiancheng Zhang
- E-mail: zhjcheng1@126.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 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;
- At least one of the following manifestations of gastrointestinal dysfunction: (1) Intra-abdominal hypertension: intra-abdominal pressure ≥12 mmHg on at least two measurements within 6 hours, or a mean pressure ≥12 mmHg based on at least four measurements within 24 hours; (2) Gastric retention: gastric residual volume >200 mL on a single aspiration; (3) Diarrhea: more than three loose or watery stools per day, with a total volume >250 mL/day; (4) Lower gastrointestinal paralysis: no bowel movement for at least 3 days, with bowel sounds present or absent, after exclusion of mechanical bowel obstruction; (5) Bowel dilatation on abdominal radiography, computed tomography, or bedside ultrasound: colonic diameter >6 cm, cecal diameter >9 cm, or small bowel diameter >3 cm;
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Žádný zásah: Kontrolní skupina
|
|
|
Experimentální: taVNS intervention group
|
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Enteral Feeding Intolerance Response Rate
Časové okno: 24-120 hours after enrollment
|
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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Serum Citrulline Concentration
Časové okno: Within 24 hours before enrollment and 24-120 hours after enrollment.
|
Change from baseline in serum citrulline concentration, used as a marker of intestinal function. |
Within 24 hours before enrollment and 24-120 hours after enrollment.
|
|
Change in Gut Microbial Diversity Measured by the Shannon Index
Časové okno: Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
|
Change from baseline in the Shannon diversity index of gut microbiota assessed using rectal swab samples. Higher values indicate greater microbial diversity. |
Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
|
|
Change in Gut Microbial Richness Measured by the Chao1 Index
Časové okno: Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
|
Change from baseline in the Chao1 richness index of gut microbiota assessed using rectal swab samples. Higher values indicate greater estimated microbial richness. |
Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
|
|
Changes in Gut Microbial Community Composition
Časové okno: Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
|
Differences in gut microbial community composition over time and between groups, assessed using Bray-Curtis dissimilarity in rectal swab samples. Higher values indicate greater differences between microbial communities. |
Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
|
|
Changes in Relative Abundance of Gut Microbial Taxa
Časové okno: Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
|
Changes from baseline in the relative abundance of gut microbial taxa at the phylum and genus levels, measured in rectal swab samples. Relative abundance is expressed as a percentage. |
Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
|
|
Changes in relative abundance of metabolites in rectal swab samples measured by liquid chromatography-tandem mass spectrometry
Časové okno: Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
|
Changes from baseline in metabolite abundances measured by metabolomic analysis of rectal swab samples. |
Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
|
|
Changes in relative abundance of metabolites in plasma samples measured by liquid chromatography-tandem mass spectrometry
Časové okno: Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
|
Changes from baseline in metabolite abundances measured by metabolomic analysis of plasma samples. |
Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
|
|
Opioid Analgesic Use
Časové okno: From enrollment through 120 hours after enrollment, or ICU discharge if earlier.
|
Cumulative and mean daily opioid doses, expressed as intravenous morphine equivalents in mg and mg/day, respectively. |
From enrollment through 120 hours after enrollment, or ICU discharge if earlier.
|
|
Propofol Use
Časové okno: From enrollment through 120 hours after enrollment, or ICU discharge if earlier.
|
Cumulative and mean daily propofol doses, expressed in mg and mg/day, respectively. |
From enrollment through 120 hours after enrollment, or ICU discharge if earlier.
|
|
Benzodiazepine Use
Časové okno: From enrollment through 120 hours after enrollment, or ICU discharge if earlier.
|
Cumulative and mean daily benzodiazepine doses, expressed as intravenous midazolam equivalents in mg and mg/day, respectively. |
From enrollment through 120 hours after enrollment, or ICU discharge if earlier.
|
|
Change in Sequential Organ Failure Assessment Score
Časové okno: Within 24 hours before enrollment and 24-120 hours after enrollment.
|
Change from baseline in the Sequential Organ Failure Assessment (SOFA) score. Scores range from 0 to 24, with higher scores indicating more severe organ dysfunction. A negative change indicates improvement. |
Within 24 hours before enrollment and 24-120 hours after enrollment.
|
|
Change in Acute Physiology and Chronic Health Evaluation II Score
Časové okno: Within 24 hours before enrollment and 24-120 hours after enrollment.
|
Change from baseline in the Acute Physiology and Chronic Health Evaluation II (APACHE II) score. Scores range from 0 to 71, with higher scores indicating greater illness severity. A negative change indicates improvement. |
Within 24 hours before enrollment and 24-120 hours after enrollment.
|
|
Vasoactive Medication Use
Časové okno: Within 24 hours before enrollment and 24-120 hours after enrollment.
|
Percentage of participants receiving any vasoactive medication during each assessment period. |
Within 24 hours before enrollment and 24-120 hours after enrollment.
|
|
Change in C-Reactive Protein Concentration
Časové okno: Within 24 hours before enrollment and 24-120 hours after enrollment.
|
Change from baseline in blood C-reactive protein concentration, a marker of inflammation. |
Within 24 hours before enrollment and 24-120 hours after enrollment.
|
|
Change in Procalcitonin Concentration
Časové okno: Within 24 hours before enrollment and 24-120 hours after enrollment.
|
Change from baseline in blood procalcitonin concentration. |
Within 24 hours before enrollment and 24-120 hours after enrollment.
|
|
Occurrence of ICU Delirium
Časové okno: up to 28 days after enrollment.
|
Percentage of participants with at least one positive delirium assessment using the Confusion Assessment Method for the ICU (CAM-ICU) during the observation period. |
up to 28 days after enrollment.
|
|
ICU Mortality
Časové okno: up to 28 days after enrollment.
|
Percentage of participants who die from any cause during the ICU stay in which they are enrolled. |
up to 28 days after enrollment.
|
|
In-Hospital Mortality
Časové okno: up to 90 days after enrollment.
|
Percentage of participants who die from any cause during the hospitalization in which they are enrolled. |
up to 90 days after enrollment.
|
|
28-Day All-Cause Mortality
Časové okno: From enrollment through Day 28.
|
Percentage of participants who die from any cause within 28 days after enrollment. |
From enrollment through Day 28.
|
|
90-Day All-Cause Mortality
Časové okno: From enrollment through Day 90.
|
Percentage of participants who die from any cause within 90 days after enrollment. |
From enrollment through Day 90.
|
|
All-Cause Hospital Readmission Within 90 Days After Discharge
Časové okno: From discharge from the index hospitalization through 90 days after discharge.
|
Percentage of participants discharged alive from the index hospitalization who are readmitted to a hospital for any cause within 90 days after discharge. |
From discharge from the index hospitalization through 90 days after discharge.
|
|
New Infections Within 90 Days
Časové okno: From randomization through Day 90.
|
Percentage of participants who develop at least one new infection within 90 days after randomization, excluding infections present at ICU admission. |
From randomization through Day 90.
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- zjc202605
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .