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

Auricular Vagus Nerve Stimulation Combined With Body Acupuncture for Gut-Brain Axis Modulation and Improved Gastrointestinal Motility in Elderly Critically Ill Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Critical Illness; Gastrointestinal Dysfunction
• Intervention / Treatment: Other: Standard Care; Behavioral: Body Acupuncture; Device: Transcutaneous Auricular Vagus Nerve Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qian Zhang; Phone Number: 86+13585177907; Email: zhangqian_907@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Care Group; Standard Care Group	Other: Standard Care; Standard ICU care including hemodynamic management, enteral nutrition support per protocol (energy target: 25 kcal/kg ideal body weight/day; protein target: 1.3 g/kg ideal body weight/day), and management of feeding complications such as diarrhea, abdominal distension, and gastric retention. Enteral nutrition is initiated within 24-48 hours of ICU admission.
Active Comparator: Body Acupuncture Group; Participants receive standard ICU care plus body acupuncture therapy. Acupuncture is performed daily by a licensed acupuncturist with 10 years of experience. Needles are inserted at acupoints including CV12, CV10, ST36, PC6, and others, retained for 30 minutes per session. The intervention continues from ICU admission until ICU discharge, death, or discontinuation of nutritional support.	Other: Standard Care; Standard ICU care including hemodynamic management, enteral nutrition support per protocol (energy target: 25 kcal/kg ideal body weight/day; protein target: 1.3 g/kg ideal body weight/day), and management of feeding complications such as diarrhea, abdominal distension, and gastric retention. Enteral nutrition is initiated within 24-48 hours of ICU admission.; Behavioral: Body Acupuncture; Acupuncture at body acupoints including CV13 (Shangwan), CV12 (Zhongwan), CV10 (Xiawan), ST21 (Liangmen), ST25 (Tianshu), SP15 (Daheng), CV4 (Guanyuan), CV6 (Qihai), CV7 (Yinjiao), LI4 (Hegu), TE6 (Zhigou), ST36 (Zusanli), ST37 (Shangjuxu), ST41 (Jiexi), and LR3 (Taichong). Sterile disposable needles (0.25mm × 40mm) are inserted 1-1.5 cun to achieve deqi sensation, retained for 30 minutes per session, once daily.
Experimental: Combined Auricular VNS and Body Acupuncture Group; Participants receive standard ICU care, body acupuncture (as described in Arm 2), and additional transcutaneous auricular vagus nerve stimulation (taVNS). A medium-frequency electrical stimulator is applied to the cymba concha region of the ear (25 Hz, 0-2 mA, 30 minutes per session, once daily). The intervention continues from ICU admission until ICU discharge, death, or discontinuation of nutritional support.	Other: Standard Care; Standard ICU care including hemodynamic management, enteral nutrition support per protocol (energy target: 25 kcal/kg ideal body weight/day; protein target: 1.3 g/kg ideal body weight/day), and management of feeding complications such as diarrhea, abdominal distension, and gastric retention. Enteral nutrition is initiated within 24-48 hours of ICU admission.; Behavioral: Body Acupuncture; Acupuncture at body acupoints including CV13 (Shangwan), CV12 (Zhongwan), CV10 (Xiawan), ST21 (Liangmen), ST25 (Tianshu), SP15 (Daheng), CV4 (Guanyuan), CV6 (Qihai), CV7 (Yinjiao), LI4 (Hegu), TE6 (Zhigou), ST36 (Zusanli), ST37 (Shangjuxu), ST41 (Jiexi), and LR3 (Taichong). Sterile disposable needles (0.25mm × 40mm) are inserted 1-1.5 cun to achieve deqi sensation, retained for 30 minutes per session, once daily.; Device: Transcutaneous Auricular Vagus Nerve Stimulation; Medium-frequency electrical stimulator (SNM-FDCM01, Ningbo Maida Medical Instruments Co., Ltd.) applied to the cymba concha region of the ear. Parameters: active period 2 seconds, rest period 3 seconds; pulse width 0.5 ms; frequency 25 Hz; intensity 0-2 mA (maximum tolerable by patient); 30 minutes per session, once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to Achieve Enteral Nutrition Target	From ICU admission up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Acute Gastrointestinal Injury (AGI) Grade		Baseline Day3 Day 7
Change in Feeding Intolerance Score (FIS)	Minimum Value: 0 (The lowest score, where all evaluation items are scored as 0). Maximum Value: 15. The score is calculated by summing three items (abdominal distension and/or pain + nausea and/or vomiting + diarrhea). Since each item has a maximum score of 5, the theoretical maximum total score is 5 + 5 + 5 = 15. Interpretation (Higher vs. Worse): Higher scores indicate a worse outcome. A higher score represents more severe feeding intolerance (e.g., severe abdominal distension, frequent vomiting, massive diarrhea), requiring stricter clinical management. According to the notes in the image: 0-2 points: Continue enteral nutrition, increase or maintain the original rate, and provide symptomatic treatment. 3-4 points: Continue enteral nutrition, slow down the rate, and reassess after 2 hours. ≥5 points: Suspend enteral nutrition and take corresponding management measures.	Baseline Day3 Day 7
Change in Gastrointestinal Dysfunction Score (GIDS)	Minimum Value: 0 (0 - No risk: No symptoms, or any of the listed conditions present at the time of oral intake). Maximum Value: 4 (4 - Life-threatening: One of the listed conditions present). Interpretation (Higher vs. Worse): Higher scores indicate a worse outcome. Higher scores represent more severe gastrointestinal dysfunction and a higher risk of mortality. The specific grades are as follows: 0 (No risk): No symptoms, or any of the following conditions present at the time of oral intake (e.g., absent bowel sounds, vomiting, gastric residual volume >200ml, etc.).; (Increased risk): Two of the following symptoms are present (e.g., no oral intake, absent bowel sounds, vomiting, gastric residual volume >200ml, etc.).; (Gastrointestinal dysfunction): Three or more symptoms scored as 1, OR two of the following symptoms (severe diarrhea, gastrointestinal bleeding requiring transfusion, intra-abdominal pressure >20 mmHg).; (Gastrointestinal failure): Three or more of the followin	Baseline Day3 Day 7
Change in Intra-Abdominal Pressure (IAP)		Baseline Day3 Day 7
Change in Plasma Levels of Intestinal Injury Biomarkers (I-FABP）	ng/mL	Baseline Day 7
Change in Plasma Levels of Intestinal Injury Biomarkers (DAO）	ng/mL	Baseline and Day 7
Proportion of Participants Requiring Supplemental Parenteral Nutrition (SPN)		Day 7
Incidence of Secondary Intestinal Infections		Up to 28 days from ICU admission
Duration of Mechanical Ventilation		Up to 28 days from ICU admission
Length of ICU Stay		Up to 28 days from ICU admission
28-Day Mortality		Day 28
Change in Plasma Levels of Citrulline	μmol/L	Baseline and Day 7

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: September 20, 2026
• First Submitted That Met QC Criteria: October 1, 2026
• First Posted (Actual): October 6, 2026

Study Record Updates

• Last Update Posted (Actual): October 6, 2026
• Last Update Submitted That Met QC Criteria: October 1, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 2026-SR-295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The de-identified individual participant data (IPD) that underlie the results reported in this article, including data dictionaries, will be made available to researchers who provide a methodologically sound proposal. Data will be available beginning 9 months and ending 36 months following article publication. Proposals should be directed to dongjiaxin1861@163.com. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Time Frame

Data will be available beginning 9 months and ending 36 months following article publication.

IPD Sharing Access Criteria

De-identified individual participant data and supporting information will be made available to researchers whose proposed use of the data has been approved by an independent review committee. Requests must be directed to the corresponding author (dongjiaxin1861@163.com) and requestors must sign a data access agreement.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No