Traditional Chinese Acupoint Massage for Gastrointestinal Function Recovery

Gastrointestinal Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06207461
• Other study ID #: ZJC202401
• Status: Not yet recruiting
• Start date: February 15, 2024
• Est. completion date: October 1, 2025

Study information

• Verified date: January 2024
• Source: Wuhan Union Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 ?-? 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 ? 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.

Related Conditions & MeSH terms

• Gastrointestinal Dysfunction

Locations

Country	Name	City	State
China	Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day survival rate (%)	Survival at 28 days after hospitalization	Up to 4 weeks
Primary	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
Primary	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 (?S = S relaxation - S contraction), and take the average of 3 measurements. Antral contraction amplitude: ?S/S relaxation.	0, 24, 48, 72, 96 and 120 hours after study inclusion
Primary	Ultrasound assessment of gastrointestinal function: MI	Motility index (MI): ACF × ACA.	0, 24, 48, 72, 96 and 120 hours after study inclusion
Primary	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
Primary	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
Primary	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
Primary	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	Daily amount of enteral nutrition feeding (ml)	Daily amount of enteral nutrition feeding	Within 5 days after study inclusion
Secondary	Daily gastric residual volume (ml)	Daily gastric residual volume	Within 5 days after study inclusion
Secondary	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
Secondary	Serum levels of citrulline (µmol/L)	Serum levels of citrulline measured by ELISA.	0, 72 and 120 hours after study inclusion
Secondary	Serum levels of diamine oxidase (DAO, U/L)	Serum levels of DAO measured by ELISA.	0, 72 and 120 hours after study inclusion
Secondary	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
Secondary	Superior mesenteric artery resistance index	Superior mesenteric artery resistance index evaluated by ultrasound	0, 72 and 120 hours after study inclusion
Secondary	Intra-abdominal pressure (IAP) (mmHg)	Intra-abdominal pressure (IAP)	0, 24, 48, 72, 96 and 120 hours after study inclusion
Secondary	Diarrhea	Yes (numbers) or No	0, 24, 48, 72, 96 and 120 hours after study inclusion
Secondary	Alimentary tract hemorrhage	Yes (numbers) or No	0, 24, 48, 72, 96 and 120 hours after study inclusion
Secondary	Prealbumin concentration (g/L)	Serum levels of prealbumin	0, 72 and 120 hours after study inclusion
Secondary	Acute physiology and chronic health evaluation (APACHE) ? 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
Secondary	ICU length of stay (days)	ICU length of stay	Up to 4 weeks
Secondary	In-hospital mortality (%)	Mortality rate during hospitalization	Up to 4 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Whole blood pH	Arterial pH measured by blood gas analysis	0, 24, 48, 72, 96 and 120 hours after study inclusion
Secondary	Arterial PaO2 (mmHg)	Arterial PaO2 measured by blood gas analysis	0, 24, 48, 72, 96 and 120 hours after study inclusion
Secondary	Arterial PaCO2 (mmHg)	Arterial PaCO2 measured by blood gas analysis	0, 24, 48, 72, 96 and 120 hours after study inclusion
Secondary	Arterial bicarbonate (mmol/L)	Arterial bicarbonate measured by blood gas analysis	0, 24, 48, 72, 96 and 120 hours after study inclusion
Secondary	Arterial lactic acid (mmol/L)	Arterial lactic acid measured by blood gas analysis	0, 24, 48, 72, 96 and 120 hours after study inclusion
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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