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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Qian Zhang
- Numéro de téléphone: 86+13585177907
- E-mail: zhangqian_907@163.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age ≥ 65 years.
- Critically ill patients admitted to the ICU with APACHE II score ≥ 15.
- NRS 2002 score ≥ 3 at ICU admission, indicating risk of malnutrition and requiring nutritional support.
- Presence of gastrointestinal dysfunction or at risk, with AGI grade I-II.
- Condition considered reversible.
- Written informed consent obtained from the participant or legal representative before any study procedures.
Exclusion Criteria:
- ICU length of stay less than 7 days.
- 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.
- Skin lesions at the acupuncture sites that are not suitable for acupuncture treatment.
- Advanced malignancy with significantly shortened life expectancy.
- Participation in another clinical trial.
- The treating clinician determines that the intervention is not in the patient's best interest.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Standard Care Group
Standard Care Group |
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. |
|
Comparateur actif: 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. |
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. 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. |
|
Expérimental: 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. |
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. 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. 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Time to Achieve Enteral Nutrition Target
Délai: From ICU admission up to 28 days
|
From ICU admission up to 28 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Acute Gastrointestinal Injury (AGI) Grade
Délai: Baseline Day3 Day 7
|
Baseline Day3 Day 7
|
|
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Change in Feeding Intolerance Score (FIS)
Délai: 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. |
Baseline Day3 Day 7
|
|
Change in Gastrointestinal Dysfunction Score (GIDS)
Délai: 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.).
|
Baseline Day3 Day 7
|
|
Change in Intra-Abdominal Pressure (IAP)
Délai: Baseline Day3 Day 7
|
Baseline Day3 Day 7
|
|
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Change in Plasma Levels of Intestinal Injury Biomarkers (I-FABP）
Délai: Baseline Day 7
|
ng/mL |
Baseline Day 7
|
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Change in Plasma Levels of Intestinal Injury Biomarkers (DAO）
Délai: Baseline and Day 7
|
ng/mL |
Baseline and Day 7
|
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Proportion of Participants Requiring Supplemental Parenteral Nutrition (SPN)
Délai: Day 7
|
Day 7
|
|
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Incidence of Secondary Intestinal Infections
Délai: Up to 28 days from ICU admission
|
Up to 28 days from ICU admission
|
|
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Duration of Mechanical Ventilation
Délai: Up to 28 days from ICU admission
|
Up to 28 days from ICU admission
|
|
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Length of ICU Stay
Délai: Up to 28 days from ICU admission
|
Up to 28 days from ICU admission
|
|
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28-Day Mortality
Délai: Day 28
|
Day 28
|
|
|
Change in Plasma Levels of Citrulline
Délai: Baseline and Day 7
|
μmol/L |
Baseline and Day 7
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-SR-295
Plan pour les données individuelles des participants (IPD)
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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.
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Data will be available beginning 9 months and ending 36 months following article publication.
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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.
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