Effects of Traditional Chinese Acupoint Massage on Gastrointestinal Function Recovery of ICU Patients: a Single-center, Prospective, Non-blind, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Ultrasound assessment of gastrointestinal function: ACF (times/min)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Ultrasound assessment of gastrointestinal function: ACF (times/min)
时间窗: 0, 24, 48, 72, 96 and 120 hours after study inclusion
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.
Ultrasound assessment of gastrointestinal function: ACA (%)
时间窗: 0, 24, 48, 72, 96 and 120 hours after study inclusion
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.
Ultrasound assessment of gastrointestinal function: intestinal motility
时间窗: 0, 24, 48, 72, 96 and 120 hours after study inclusion
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.
28-day survival rate (%)
时间窗: Up to 4 weeks
Survival at 28 days after hospitalization
Ultrasound assessment of gastrointestinal function: MI
时间窗: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Motility index (MI): ACF × ACA.
Ultrasound assessment of gastrointestinal function: GET (min)
时间窗: 0, 24, 48, 72, 96 and 120 hours after study inclusion
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.
Ultrasound assessment of gastrointestinal function: intestinal wall thickness (mm)
时间窗: 0, 24, 48, 72, 96 and 120 hours after study inclusion
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.
Ultrasound assessment of gastrointestinal function: intestinal diameter (cm)
时间窗: 0, 24, 48, 72, 96 and 120 hours after study inclusion
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.
次要结局
- Alimentary tract hemorrhage(0, 24, 48, 72, 96 and 120 hours after study inclusion)
- Acute physiology and chronic health evaluation (APACHE) Ⅱ score(0, 24, 48, 72, 96 and 120 hours after study inclusion)
- Serum levels of intestinal fatty acid binding protein (iFABP, ng/ml)(0, 72 and 120 hours after study inclusion)
- Intra-abdominal pressure (IAP) (mmHg)(0, 24, 48, 72, 96 and 120 hours after study inclusion)
- Diarrhea(0, 24, 48, 72, 96 and 120 hours after study inclusion)
- Absolute number of white blood cells in the peripheral venous blood (number/L)(0, 24, 48, 72, 96 and 120 hours after study inclusion)
- Daily amount of enteral nutrition feeding (ml)(Within 5 days after study inclusion)
- Serum levels of citrulline (μmol/L)(0, 72 and 120 hours after study inclusion)
- Serum levels of D-lactic acid (mmol/L)(0, 72 and 120 hours after study inclusion)
- Peripheral venous blood CRP concentration (mg/L)(0, 24, 48, 72, 96 and 120 hours after study inclusion)
- Peripheral venous blood hemoglobin concentration (g/L)(0, 24, 48, 72, 96 and 120 hours after study inclusion)
- Whole blood pH(0, 24, 48, 72, 96 and 120 hours after study inclusion)
- Daily gastric residual volume (ml)(Within 5 days after study inclusion)
- Serum levels of diamine oxidase (DAO, U/L)(0, 72 and 120 hours after study inclusion)
- Superior mesenteric artery resistance index(0, 72 and 120 hours after study inclusion)
- Prealbumin concentration (g/L)(0, 72 and 120 hours after study inclusion)
- ICU length of stay (days)(Up to 4 weeks)
- In-hospital mortality (%)(Up to 4 weeks)
- Absolute number of platelets in the peripheral venous blood (number/L)(0, 24, 48, 72, 96 and 120 hours after study inclusion)
- Absolute number of lymphocytes in the peripheral venous blood (number/L)(0, 24, 48, 72, 96 and 120 hours after study inclusion)
- Arterial PaO2 (mmHg)(0, 24, 48, 72, 96 and 120 hours after study inclusion)
- Arterial PaCO2 (mmHg)(0, 24, 48, 72, 96 and 120 hours after study inclusion)
- Arterial bicarbonate (mmol/L)(0, 24, 48, 72, 96 and 120 hours after study inclusion)
- Arterial lactic acid (mmol/L)(0, 24, 48, 72, 96 and 120 hours after study inclusion)
- Peripheral venous blood creatinine concentration (μmol/L)(0, 24, 48, 72, 96 and 120 hours after study inclusion)
- Peripheral venous blood albumin concentration (g/L)(0, 24, 48, 72, 96 and 120 hours after study inclusion)
- Peripheral venous blood total bilirubin concentration (μmol/L)(0, 24, 48, 72, 96 and 120 hours after study inclusion)
- Peripheral venous blood bound bilirubin concentration (μmol/L)(0, 24, 48, 72, 96 and 120 hours after study inclusion)
- Peripheral venous blood AST concentration (U/L)(0, 24, 48, 72, 96 and 120 hours after study inclusion)
- Peripheral venous blood ALT concentration (U/L)(0, 24, 48, 72, 96 and 120 hours after study inclusion)
研究者
Jiancheng Zhang
Prof. Jiancheng Zhang
Wuhan Union Hospital, China