Gastrointestinal Dysfunction, Critical Illness
Conditions
Brief 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.
Interventions
OTHERStandard 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.
BEHAVIORALBody 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.
DEVICETranscutaneous 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.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Achieve Enteral Nutrition Target | From ICU admission up to 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Acute Gastrointestinal Injury (AGI) Grade | Baseline Day3 Day 7 | — |
| Change in Feeding Intolerance Score (FIS) | Baseline Day3 Day 7 | 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. |
| Change in Gastrointestinal Dysfunction Score (GIDS) | Baseline Day3 Day 7 | 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.). 1. (Increased risk): Two of the following symptoms are present (e.g., no oral intake, absent bowel sounds, vomiting, gastric residual volume \>200ml, etc.). 2. (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). 3. (Gastrointestinal failure): Three or more of the followin |
| Change in Intra-Abdominal Pressure (IAP) | Baseline Day3 Day 7 | — |
| Change in Plasma Levels of Intestinal Injury Biomarkers (I-FABP） | Baseline Day 7 | ng/mL |
| Change in Plasma Levels of Intestinal Injury Biomarkers (DAO） | Baseline and Day 7 | ng/mL |
| 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 | Baseline and Day 7 | μmol/L |
Contacts
CONTACTQian Zhang
Outcome results
None listed