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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Qian Zhang
- Número de teléfono: 86+13585177907
- Correo electrónico: zhangqian_907@163.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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. |
|
Comparador activo: 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. |
|
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. |
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Time to Achieve Enteral Nutrition Target
Periodo de tiempo: From ICU admission up to 28 days
|
From ICU admission up to 28 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Acute Gastrointestinal Injury (AGI) Grade
Periodo de tiempo: Baseline Day3 Day 7
|
Baseline Day3 Day 7
|
|
|
Change in Feeding Intolerance Score (FIS)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: Baseline Day3 Day 7
|
Baseline Day3 Day 7
|
|
|
Change in Plasma Levels of Intestinal Injury Biomarkers (I-FABP）
Periodo de tiempo: Baseline Day 7
|
ng/mL |
Baseline Day 7
|
|
Change in Plasma Levels of Intestinal Injury Biomarkers (DAO）
Periodo de tiempo: Baseline and Day 7
|
ng/mL |
Baseline and Day 7
|
|
Proportion of Participants Requiring Supplemental Parenteral Nutrition (SPN)
Periodo de tiempo: Day 7
|
Day 7
|
|
|
Incidence of Secondary Intestinal Infections
Periodo de tiempo: Up to 28 days from ICU admission
|
Up to 28 days from ICU admission
|
|
|
Duration of Mechanical Ventilation
Periodo de tiempo: Up to 28 days from ICU admission
|
Up to 28 days from ICU admission
|
|
|
Length of ICU Stay
Periodo de tiempo: Up to 28 days from ICU admission
|
Up to 28 days from ICU admission
|
|
|
28-Day Mortality
Periodo de tiempo: Day 28
|
Day 28
|
|
|
Change in Plasma Levels of Citrulline
Periodo de tiempo: Baseline and Day 7
|
μmol/L |
Baseline and Day 7
|
Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-SR-295
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Marco de tiempo para compartir IPD
Data will be available beginning 9 months and ending 36 months following article publication.
Criterios de acceso compartido de IPD
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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .