Traditional Chinese Acupoint Massage for Gastrointestinal Function Recovery

NCT ID: NCT06207461

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-10-01

Brief Summary

Patients in the intensive care unit (ICU) are often at risk of gastrointestinal dysfunction and malnutrition. Gastrointestinal dysfunction was associated with poor clinical outcomes, including prolonged mechanical ventilation, prolonged ICU stay and increased 90-day mortality.

There have been some clinical studies investigating the effects of traditional Chinese acupoint massage, acupuncture, or moxibustion of 7 acupoints (Zhongwan Point (CV12), Tianshu Point (ST25), Qihai Point (CV6), Zusanli point (ST36), Shangjuxu Point (ST37), Neiguan Point (PC6) and Hegu Point (LI4)) on gastrointestinal function recovery. Gastrointestinal dysfunction could be improved by stimulating single acupoint or combining multiple acupoints, and the effects of combined stimulation of multiple acupoints was better for the improvement of gastrointestinal dysfunction.

This project aims to study the effects of traditional Chinese acupoint massage, acupuncture, or moxibustion of 7 acupoints (Zhongwan Point (CV12), Tianshu Point (ST25), Qihai Point (CV6), Zusanli point (ST36), Shangjuxu Point (ST37), Neiguan Point (PC6) and Hegu Point (LI4)) on the 28-day survival, and the gastrointestinal function recovery in critically ill patients with with gastrointestinal dysfunction caused by medical diseases and critically ill patients with high risk of malnutrition in ICU, and to observe their effects on the recovery of gastrointestinal barrier function by measuring the serum intestinal fatty acid binding protein (iFABP), citrulline, diamine oxidase (DAO) and D-lactic acid. Studies have shown that serum iFABP, citrulline, DAO and D-lactic acid could reflect the intestinal barrier function of the patients.

Conditions

Traditional Chinese Acupoint Message; Intestinal Barrier; Gastrointestinal Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

massage group

patients with gastrointestinal function injury caused by medical diseases or with high risk of malnutrition who got massage

No interventions assigned to this group

non-massage group

patients with gastrointestinal function injury caused by medical diseases or with high risk of malnutrition who got no massage

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Patients aged 18-80 years old without restriction of gender, race, religion, creed or nationality;

2. Patients with high risk of malnutrition due to gastrointestinal dysfunction caused by medical diseases, and AGI score Ⅰ-Ⅱ or NRS 2002 score ≥3 points;

3. Patients with hospital stay longer than 120 hours;

4. Willing to participate in this trial.

Exclusion Criteria

1. Patients with abdominal open trauma;

2. Defects, infections or lesions in the skin near the acupoints；

3. Patients with abdominal tumor or large amount of abdominal fluid;

4. Patients with AGI score Ⅲ or above;

5. Pregnant patients;

6. Patients with Child-Pugh grade B and grade C liver function

7. Unable or unwilling to provide informed consent or poor compliance.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Jiancheng Zhang

Prof. Jiancheng Zhang

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Countries

China

Other Identifiers

ZJC202401

Identifier Type: -

Identifier Source: org_study_id