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| ID | Type | Description | Link |
|---|---|---|---|
| 2026ZDSYLL103-P01 | Other Identifier | Zhongda Hospital Affiliated to Southeast University |
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Mechanical ventilation is a common method of respiratory support for critically ill patients, and gastrointestinal dysfunction (GIDF) is a frequent complication. In the ICU, more than 60% of mechanically ventilated patients experience gastrointestinal dysfunction. Currently, the exact causes of mechanical ventilation-induced gastrointestinal dysfunction remain unclear, but they primarily include increased intra-abdominal pressure resulting from positive-pressure ventilation, which inhibits gastrointestinal motility; inflammatory responses, prolonged bed rest, electrolyte imbalances, and the use of sedatives, analgesics, and even muscle relaxants . Manifestations such as gastroparesis and constipation further lead to delayed gastric emptying, increased intra-abdominal pressure, and heightened risks of bacterial translocation, multiple organ failure, and ventilator-associated pneumonia. Primary Objective is to investigate, through a prospective randomized controlled trial, the efficacy of neostigmine injection at the Zusanli acupoint compared to Zusanli acupoint stimulation alone or subcutaneous neostigmine injection in improving gastrointestinal function in patients with mechanical ventilation and gastrointestinal dysfunction. Secondary objectives: （1）To evaluate the effects of acupoint injection of neostigmine on the duration of mechanical ventilation, enteral nutrition intake, and ICU length of stay in critically ill patients; （2）To assess the safety of acupoint injection of neostigmine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neostigmine injection at the acupoints | Experimental |
| |
| intramuscular injection of normal saline | Active Comparator |
| |
| subcutaneous injection of neostigmine | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neostigmine Acupoint Injection | Drug | On the basis of standard treatment, neostigmine was injected into the bilateral Zusanli (ST36) acupoints. The patient was placed in the supine position with knees flexed. Following routine local disinfection, a 5 mL disposable syringe was used to extract 0.5 mg of neostigmine for vertical subcutaneous needling and injection. Upon needle withdrawal, the puncture site was compressed with sterile cotton swabs for hemostasis. The identical procedure was applied to the contralateral Zusanli acupoint. The intervention period is 1 day, with interventions administered twice daily (bid), 12 hours apart. |
| Measure | Description | Time Frame |
|---|---|---|
| Remission rate of gastrointestinal symptoms within 24 hours | Gastrointestinal symptom relief is defined as meeting both recovery of spontaneous defecation (i.e., the first defecation after initial intervention with a defecation volume > 100 mL) and improvement in 24-hour gastric retention (24-hour gastric retention volume ≤ 500 mL). | within 24 hours after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day mortality | Mortality was calculated on day 28 of treatment | From randomization to Day 28 |
| ICU mortality | the survival rate(survival/total) during ICU stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Airan Liu professor | Contact | 8615295557466 | airanliu@126.com |
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| Neostigmine subcutaneous injection | Drug | On the basis of standard treatment, subcutaneous injection was performed at non-acupoint sites. A 5 mL disposable syringe was used to aspirate 1 mg of neostigmine injection for single-site injection. The injection site received routine disinfection beforehand. Following the injection, the needle was withdrawn, and the puncture site was compressed with sterile cotton swabs for hemostasis.The intervention period is 1 day, with interventions administered twice daily (bid), 12 hours apart. |
|
| Acupoint normal saline injection | Drug | On the basis of standard treatment, normal saline was injected into bilateral Zusanli (ST36) acupoints. The patient was placed in the supine position with knees flexed. After routine local disinfection, a 5 mL disposable syringe was used for vertical needle insertion, and an equal volume of normal saline was injected subcutaneously into each acupoint. Following injection, the needle was withdrawn, and the puncture site was compressed with sterile cotton swabs for hemostasis.The intervention period is 1 day, with interventions administered twice daily (bid), 12 hours apart. |
|
| up to 24 months |
| Length of ICU stay | Time of staying in ICU within 28 days | up to 28 days |
| Infection condition | Infection condition within 28 days | From randomization to Day 28 |
| 28-day vasopressor-free days | 28-day vasopressor-free days is defined as a continuous period of 28 days, beginning from the time a patient is weaned from shock, circulatory failure, or mechanical circulatory support, during which no vasoactive drugs are used at any time, and the patient maintains stable circulation without the need for vasopressors agents to sustain blood pressure and tissue perfusion. | From randomization to Day 28 |
| 28-day ventilator-free days | Ventilator-free days are defined as the number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization. | From randomization to Day 28 |
| Length of hospital stay | Length of hospital stay | prior to hospital discharge |
| Enteral Nutrition Prescription | Enteral Nutrition Prescription was recorded before treatment,on day 1 of treatment,on day 3 of treatment,and on day 7 of treatment. | before treatment,on day 1 of treatment,on day 3 of treatment,on day 7 of treatment |
| Intra-abdominal pressure(mmHg) | The patient was placed in the supine position. A urinary catheter was inserted transurethrally and connected to a three-way stopcock. Then 25 mL of 0.9% normal saline was injected. Taking the level of the pubic symphysis as the zero point, the water column height at the end of expiration was measured and recorded.IAP readings must be converted to mmHg. | before treatment,on day 1 of treatment,on day 3 of treatment |
| Bowel sounds | Bowel sounds (times/min) were auscultated daily at a fixed time point before and after treatment over the right lower abdomen with a stethoscope. Each continuous auscultation lasted 3 minutes; the frequency of bowel sounds per minute was recorded, and the mean value of three repeated measurements was calculated. | before treatment,on day 1 of treatment,on day 3 of treatment |
| motilin | Venous blood samples of 2 mL were collected in the early morning before treatment, on day 1 and day 3 after treatment. The levels of motilin (MTL) were determined and recorded. | before treatment,on day 1 of treatment,on day 3 of treatment |
| gastrin | Venous blood samples of 2 mL were collected in the early morning before treatment, on day 1 and day 3 after treatment. The levels of gastrin (GAS) were determined and recorded. | before treatment,on day 1 of treatment,on day 3 of treatment |
| vasoactive intestinal peptide | Venous blood samples of 2 mL were collected in the early morning before treatment, on day 1 and day 3 after treatment. The levels of vasoactive intestinal peptide (VIP) were determined and recorded. | before treatment,on day 1 of treatment,on day 3 of treatment |
| electrogastroenterography changes:FP(cpm) | An electrogastroenterograph (Model EGEG-8D) was adopted. During examination, all subjects were placed in the supine position. Electrogastroenterography was performed before treatment, at 1 day and 3 days after treatment, and the main frequency (FP) (cpm) were recorded. | before treatment,on day 1 of treatment,on day 3 of treatment |
| hemoglobin | Hemoglobin(g/L) are measured at baseline ,Day1, and Day3 as a marker of nutritional condition. | before treatment,on day 1 of treatment,on day 3 of treatment |
| albumin | Serum albumin levels(g/L) are measured at baseline ,Day1, and Day3 as a marker of nutritional condition. | before treatment,on day 1 of treatment,on day 3 of treatment |
| prealbumin | Serum prealbumin levels(mg/L) are measured at baseline ,Day1, and Day3 as a marker of nutritional condition. | before treatment,on day 1 of treatment,on day 3 of treatment |
| White blood cell count | Serum White blood cell count (10^9/L) is measured at baseline ,Day1, and Day3 as a marker of a systemic inflammatory response. | before treatment, on day 1 of treatment, on day 3 of treatment |
| Lymphocyte count | Serum lymphocyte count (10^9/L) is measured at baseline ,Day1, and Day3 as a marker of a systemic inflammatory response. | before treatment, on day 1 of treatment, on day 3 of treatment |
| C-reactive protein | Serum C-reactive protein levels(mg/L) are measured at baseline ,Day1, and Day3 as a marker of a systemic inflammatory response. | before treatment, on day 1 of treatment, on day 3 of treatment |
| Procalcitonin | Serum procalcitonin protein levels(ng/mL) are measured at baseline ,Day1, and Day3 as a marker of a systemic inflammatory response. | before treatment, on day 1 of treatment, on day 3 of treatment |
| electrogastroenterography changes:FC(cpm) | An electrogastroenterograph (Model EGEG-8D) was adopted. During examination, all subjects were placed in the supine position. Electrogastroenterography was performed before treatment, at 1 day and 3 days after treatment, and the mean frequency (FC) were recorded. | before treatment, on day 1 of treatment, on day 3 of treatment |
| electrogastroenterography changes:AP(uV) | An electrogastroenterograph (Model EGEG-8D) was adopted. During examination, all subjects were placed in the supine position. Electrogastroenterography was performed before treatment, at 1 day and 3 days after treatment, and amplitude was recorded. | before treatment, on day 1 of treatment, on day 3 of treatment |
| Actual feeding amount | Actual feeding amount (kcal)was recorded before treatment, on day 1 of treatment, on day 3 of treatment, on day 7 of treatment. | before treatment, on day 1 of treatment, on day 3 of treatment, on day 7 of treatment. |
| Intestinal diameter | Using a Philips ultrasound machine, the intestinal diameter（cm） was assessed by scanning with a convex probe while the patient was in the supine position before treatment, 1 day after treatment, and 3 days after treatment. | before treatment, on day 1 of treatment, on day 3 of treatment |