Traditional Chinese Acupoint Massage for Gastrointestinal Function Recovery

Effects of Traditional Chinese Acupoint Massage on Gastrointestinal Function Recovery of ICU Patients: a Single-center, Prospective, Non-blind, Randomized Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastrointestinal Dysfunction; Traditional Chinese Acupoint Message; Intestinal Barrier

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily amount of enteral nutrition feeding (ml)	Daily amount of enteral nutrition feeding	Within 5 days after study inclusion
Daily gastric residual volume (ml)	Daily gastric residual volume	Within 5 days after study inclusion
Serum levels of intestinal fatty acid binding protein (iFABP, ng/ml)	Serum levels of iFABP measured by ELISA.	0, 72 and 120 hours after study inclusion
Serum levels of citrulline (μmol/L)	Serum levels of citrulline measured by ELISA.	0, 72 and 120 hours after study inclusion
Serum levels of diamine oxidase (DAO, U/L)	Serum levels of DAO measured by ELISA.	0, 72 and 120 hours after study inclusion
Serum levels of D-lactic acid (mmol/L)	Serum levels of D-lactic acid measured by ELISA.	0, 72 and 120 hours after study inclusion
Superior mesenteric artery resistance index	Superior mesenteric artery resistance index evaluated by ultrasound	0, 72 and 120 hours after study inclusion
Intra-abdominal pressure (IAP) (mmHg)	Intra-abdominal pressure (IAP)	0, 24, 48, 72, 96 and 120 hours after study inclusion
Diarrhea	Yes (numbers) or No	0, 24, 48, 72, 96 and 120 hours after study inclusion
Alimentary tract hemorrhage	Yes (numbers) or No	0, 24, 48, 72, 96 and 120 hours after study inclusion
Prealbumin concentration (g/L)	Serum levels of prealbumin	0, 72 and 120 hours after study inclusion
Acute physiology and chronic health evaluation (APACHE) Ⅱ score	0-67, higher scores correspond to more severe disease and a higher risk of death	0, 24, 48, 72, 96 and 120 hours after study inclusion
ICU length of stay (days)	ICU length of stay	Up to 4 weeks
In-hospital mortality (%)	Mortality rate during hospitalization	Up to 4 weeks
Peripheral venous blood CRP concentration (mg/L)	CRP level measured by blood routine examination	0, 24, 48, 72, 96 and 120 hours after study inclusion
Peripheral venous blood hemoglobin concentration (g/L)	Hemoglobin level measured by blood routine examination	0, 24, 48, 72, 96 and 120 hours after study inclusion
Absolute number of white blood cells in the peripheral venous blood (number/L)	Absolute number of white blood cells measured by blood routine examination	0, 24, 48, 72, 96 and 120 hours after study inclusion
Absolute number of platelets in the peripheral venous blood (number/L)	Absolute number of platelets measured by blood routine examination	0, 24, 48, 72, 96 and 120 hours after study inclusion
Absolute number of lymphocytes in the peripheral venous blood (number/L)	Absolute number of lymphocytes measured by blood routine examination	0, 24, 48, 72, 96 and 120 hours after study inclusion
Whole blood pH	Arterial pH measured by blood gas analysis	0, 24, 48, 72, 96 and 120 hours after study inclusion
Arterial PaO2 (mmHg)	Arterial PaO2 measured by blood gas analysis	0, 24, 48, 72, 96 and 120 hours after study inclusion
Arterial PaCO2 (mmHg)	Arterial PaCO2 measured by blood gas analysis	0, 24, 48, 72, 96 and 120 hours after study inclusion
Arterial bicarbonate (mmol/L)	Arterial bicarbonate measured by blood gas analysis	0, 24, 48, 72, 96 and 120 hours after study inclusion
Arterial lactic acid (mmol/L)	Arterial lactic acid measured by blood gas analysis	0, 24, 48, 72, 96 and 120 hours after study inclusion
Peripheral venous blood albumin concentration (g/L)	Albumin level measured by Blood biochemical examination	0, 24, 48, 72, 96 and 120 hours after study inclusion
Peripheral venous blood total bilirubin concentration (μmol/L)	Total bilirubin level measured by Blood biochemical examination	0, 24, 48, 72, 96 and 120 hours after study inclusion
Peripheral venous blood bound bilirubin concentration (μmol/L)	Bound bilirubin level measured by Blood biochemical examination	0, 24, 48, 72, 96 and 120 hours after study inclusion
Peripheral venous blood creatinine concentration (μmol/L)	Creatinine level measured by Blood biochemical examination	0, 24, 48, 72, 96 and 120 hours after study inclusion
Peripheral venous blood ALT concentration (U/L)	ALT level measured by Blood biochemical examination	0, 24, 48, 72, 96 and 120 hours after study inclusion
Peripheral venous blood AST concentration (U/L)	AST level measured by Blood biochemical examination	0, 24, 48, 72, 96 and 120 hours after study inclusion

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: December 3, 2023
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 27, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Intensive care unit; Intestinal barrier; Gastrointestinal dysfunction; Acupoint massage; Gastrointestinal function recovery
• Other Study ID Numbers: ZJC202401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No