Traditional Chinese Acupoint Massage for Gastrointestinal Function Recovery

NCT06207461 | Withdrawn DMC

• 1 other identifier: ZJC202401
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Acupoint massage; Gastrointestinal dysfunction; Gastrointestinal function recovery; Intensive care unit; Intestinal barrier

Outcome Measures

Primary Outcomes (8)

• 28-day survival rate (%)

  Survival at 28 days after hospitalization

  Up to 4 weeks

• Ultrasound assessment of gastrointestinal function: ACF (times/min)

  Antral contraction frequency (ACF): In semi-recumbent position at 45°, infuse the stomach with 300ml of warm water. Within 6 minutes after infusion, divide the number of antral contractions by 3.

  0, 24, 48, 72, 96 and 120 hours after study inclusion

• Ultrasound assessment of gastrointestinal function: ACA (%)

  Antral contraction amplitude (ACA): Measure the area during 3 maximum relaxations (S relaxation) and minimum contractions (S contraction), calculate the change in antral area (ΔS = S relaxation - S contraction), and take the average of 3 measurements. Antral contraction amplitude: ΔS/S relaxation.

  0, 24, 48, 72, 96 and 120 hours after study inclusion

• Ultrasound assessment of gastrointestinal function: MI

  Motility index (MI): ACF × ACA.

  0, 24, 48, 72, 96 and 120 hours after study inclusion

• Ultrasound assessment of gastrointestinal function: GET (min)

  Gastric emptying time (GET): In semi-recumbent position at 45°, infuse the stomach with 300ml of warm water. Use the maximum antral relaxation as the standard and measure the area every 5 minutes until the liquid in the antrum is emptied. The time it takes for the gastric antrum to empty is GET.

  0, 24, 48, 72, 96 and 120 hours after study inclusion

• Ultrasound assessment of gastrointestinal function: intestinal wall thickness (mm)

  Intestinal wall thickness of Jejunum/Ileum/Colon: Refers to the distance between the serosal and mucosal surfaces of the intestinal wall. The normal thickness of the small intestine is 2-3mm, and \>3mm may indicate thickening of the intestinal wall; the thickness of the colon wall is approximately 3-4mm, and \>5mm may suggest thickening of the intestinal wall. Attention should be paid to the colon pocket and the plica structure on the colon wall.

  0, 24, 48, 72, 96 and 120 hours after study inclusion

• Ultrasound assessment of gastrointestinal function: intestinal diameter (cm)

  Intestinal diameter of Jejunum/Ileum/Colon: When not under pressure, the measurement of the width of the small intestine often refers to the distance between the mucosal surfaces of the intestinal wall. The intestinal lumen width of the small intestine (jejunum/ileum) is generally \<2cm, and \>3cm may indicate intestinal dilation; the internal diameter of the colon is generally \<5cm.

  0, 24, 48, 72, 96 and 120 hours after study inclusion

• Ultrasound assessment of gastrointestinal function: intestinal motility

  Intestinal motility of Jejunum/Ileum/Colon (yes or no): Under normal circumstances, intestinal movement can be clearly judged at the ultrasound interface. When the intestine is filled with gas or accompanied by intestinal dilation, intestinal motility can be judged by the "creeping gas sign" of the gas or the movement of the contents. In addition, attention should be paid to the intestinal motility caused by the pressure on the intestinal tube when moving the probe.

  0, 24, 48, 72, 96 and 120 hours after study inclusion

Secondary Outcomes (30)

• Daily amount of enteral nutrition feeding (ml)

  Within 5 days after study inclusion

• Daily gastric residual volume (ml)

  Within 5 days after study inclusion

• Serum levels of intestinal fatty acid binding protein (iFABP, ng/ml)

  0, 72 and 120 hours after study inclusion

• Serum levels of citrulline (μmol/L)

  0, 72 and 120 hours after study inclusion

• Serum levels of diamine oxidase (DAO, U/L)

  0, 72 and 120 hours after study inclusion

Study Arms (2)

massage group

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

non-massage group

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult critically ill patients at high risk of malnutrition due to gastrointestinal functional impairment caused by medical diseases in the ICU, and AGI grade I-II or NRS 2002 score ≥3.

You may qualify if:

• Patients aged 18-80 years old without restriction of gender, race, religion, creed or nationality;
• 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;
• Patients with hospital stay longer than 120 hours;
• Willing to participate in this trial.

You may not qualify if:

• Patients with abdominal open trauma;
• Defects, infections or lesions in the skin near the acupoints；
• Patients with abdominal tumor or large amount of abdominal fluid;
• Patients with AGI score Ⅲ or above;
• Pregnant patients;
• Patients with Child-Pugh grade B and grade C liver function
• Unable or unwilling to provide informed consent or poor compliance.

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430022, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Jiancheng Zhang

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: January 17, 2024
• Study Start: October 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)