Study on Neostigmine Acupoint Injection at Zusanli(ST36) for Treating Mechanical Ventilation-Associated Gastrointestinal Dysfunction
A Single-Center,Randomized Controlled Study on Neostigmine Acupoint Injection at Zusanli(ST36) for Treating Mechanical Ventilation-Associated Gastrointestinal Dysfunction
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Airan Liu professor
- Telefonnummer: 8615295557466
- E-mail: airanliu@126.com
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Respiratory failure due to any cause requiring mechanical ventilation, with an anticipated duration of mechanical ventilation of ≥48 hours;
- No spontaneous bowel movements for ≥48 hours or increased gastric residual volume (gastric residual volume >500 mL within 24 hours);
- Anticipated ICU stay of ≥3 days;
- Age ≥18 years and ≤85 years.
Exclusion Criteria:
- Use of prokinetic agents, subcutaneous or acupoint injections of neostigmine, or acupuncture at the Zusanli acupoint within 12 hours prior to enrollment;
- History of gastrointestinal surgery within the past 8 weeks; diarrhea within the past week; or history of severe gastrointestinal diseases such as mechanical intestinal obstruction, intestinal ischemia and necrosis, inflammatory bowel disease, or active gastrointestinal bleeding;
- Patients with an allergy to neostigmine or contraindications to its use, such as mechanical intestinal obstruction, urinary tract obstruction, bronchial asthma, bradycardia, hypotension, epilepsy, or Parkinson's disease;
- Patients unable to undergo acupoint injection due to skin lesions, infection, limb loss, or inability to cooperate at the Zusanli acupoint;
- Patients currently requiring routine treatment with neostigmine or similar cholinesterase inhibitors for other indications (e.g., myasthenia gravis, multiple sclerosis, Parkinson's disease);
- Patients with a platelet count <50 × 10⁹/L on complete blood count or severe coagulation disorders (International Normalized Ratio [INR] >3);
- Severe hepatic impairment (Child-Pugh Class C) or hepatic encephalopathy;
- End-stage renal failure requiring dialysis prior to admission;
- Patients with hemodynamic instability (norepinephrine equivalent > 1.0 μg/kg·min);
- Patients who have participated in other interventional clinical trials within the past month;
- Pregnant, perinatal, or lactating women.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: neostigmine injection at the acupoints
|
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.
|
|
Aktiv komparator: intramuscular injection of normal saline
|
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.
|
|
Aktiv komparator: subcutaneous injection of neostigmine
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Remission rate of gastrointestinal symptoms within 24 hours
Tidsramme: within 24 hours after treatment
|
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
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
ICU-dødelighed
Tidsramme: op til 24 måneder
|
overlevelsesprocenten (overlevelse/total) under intensiv behandling
|
op til 24 måneder
|
|
28-day mortality
Tidsramme: From randomization to Day 28
|
Mortality was calculated on day 28 of treatment
|
From randomization to Day 28
|
|
Length of ICU stay
Tidsramme: up to 28 days
|
Time of staying in ICU within 28 days
|
up to 28 days
|
|
Infection condition
Tidsramme: From randomization to Day 28
|
Infection condition within 28 days
|
From randomization to Day 28
|
|
28-day vasopressor-free days
Tidsramme: From randomization to Day 28
|
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
Tidsramme: From randomization to Day 28
|
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
Tidsramme: prior to hospital discharge
|
Length of hospital stay
|
prior to hospital discharge
|
|
Enteral Nutrition Prescription
Tidsramme: before treatment,on day 1 of treatment,on day 3 of treatment,on day 7 of treatment
|
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)
Tidsramme: before treatment,on day 1 of treatment,on day 3 of treatment
|
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
Tidsramme: before treatment,on day 1 of treatment,on day 3 of treatment
|
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
Tidsramme: before treatment,on day 1 of treatment,on day 3 of treatment
|
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
Tidsramme: before treatment,on day 1 of treatment,on day 3 of treatment
|
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
Tidsramme: before treatment,on day 1 of treatment,on day 3 of treatment
|
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)
Tidsramme: before treatment,on day 1 of treatment,on day 3 of treatment
|
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
Tidsramme: before treatment,on day 1 of treatment,on day 3 of treatment
|
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
Tidsramme: before treatment,on day 1 of treatment,on day 3 of treatment
|
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
Tidsramme: before treatment,on day 1 of treatment,on day 3 of treatment
|
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
Tidsramme: before treatment, on day 1 of treatment, on day 3 of treatment
|
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
Tidsramme: before treatment, on day 1 of treatment, on day 3 of treatment
|
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
Tidsramme: before treatment, on day 1 of treatment, on day 3 of treatment
|
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
Tidsramme: before treatment, on day 1 of treatment, on day 3 of treatment
|
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)
Tidsramme: before treatment, on day 1 of treatment, on day 3 of treatment
|
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)
Tidsramme: before treatment, on day 1 of treatment, on day 3 of treatment
|
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
Tidsramme: before treatment, on day 1 of treatment, on day 3 of treatment, on day 7 of treatment.
|
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
Tidsramme: before treatment, on day 1 of treatment, on day 3 of treatment
|
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
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- ST36 Acupoint injection
- 2026ZDSYLL103-P01 (Anden identifikator: Zhongda Hospital Affiliated to Southeast University)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .