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Not Yet Recruiting NCT07861503

Ear-Vagus Nerve Stimulation and Body Acupuncture for Gut Motility in Elderly ICU Patients

Conditions: Gastrointestinal Dysfunction, Critical Illness

Sex: All
Ages: 65 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: The First Affiliated Hospital with Nanjing Medical University

Summary

This study aims to investigate whether acupuncture, specifically a combination of body acupuncture and ear vagus nerve stimulation (taVNS), can improve gastrointestinal function in critically ill elderly patients in the Intensive Care Unit (ICU). Gastrointestinal motility problems, such as delayed stomach emptying and constipation, are common in elderly ICU patients and can interfere with feeding, increase infection risk, and worsen outcomes. This research will test if adding acupuncture to standard care helps patients tolerate tube feeding (enteral nutrition) faster, reduces the need for intravenous nutrition, and improves overall recovery. Participants will be randomly assigned to one of three groups: standard care alone, standard care plus body acupuncture, or standard care plus both body acupuncture and ear vagus nerve stimulation. The study will compare the time it takes to achieve target feeding goals, changes in gastrointestinal function scores, and other clinical outcomes. This single-center, prospective, randomized controlled trial will enroll 60 elderly patients from the Geriatric ICU of Jiangsu Province Hospital and aims to provide evidence for integrating traditional Chinese medicine into critical care practice.

Eligibility Criteria

Inclusion Criteria: 1. Age ≥ 65 years. 2. Critically ill patients admitted to the ICU with APACHE II score ≥ 15. 3. NRS 2002 score ≥ 3 at ICU admission, indicating risk of malnutrition and requiring nutritional support. 4. Presence of gastrointestinal dysfunction or at risk, with AGI grade I-II. 5. Condition considered reversible. 6. Written informed consent obtained from the participant or legal representative before any study procedures. Exclusion Criteria: 1. ICU length of stay less than 7 days. 2. Presence of severe gastrointestinal disease with contraindications to enteral nutrition and inability to receive conventional medications via the enteral route, such as acute gastrointestinal bleeding, mechanical intestinal obstruction, post-abdominal surgery, or abdominal compartment syndrome. 3. Skin lesions at the acupuncture sites that are not suitable for acupuncture treatment. 4. Advanced malignancy with significantly shortened life expectancy. 5. Participation in another clinical trial. 6. The treating clinician determines that the intervention is not in the patient's best interest.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07861503). StuddyBuddy aggregates publicly available trial information.