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
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Tipo de estudo
Tipo de estudo
Inscrição (Estimado)
Inscrição
Estágio
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
Contato de estudo
- Nome: Airan Liu professor
- Número de telefone: 8615295557466
- E-mail: airanliu@126.com
Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
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Experimental: neostigmine injection at the acupoints
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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.
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Comparador Ativo: intramuscular injection of normal saline
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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.
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Comparador Ativo: subcutaneous injection of neostigmine
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Remission rate of gastrointestinal symptoms within 24 hours
Prazo: within 24 hours after treatment
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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).
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within 24 hours after treatment
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Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mortalidade na UCI
Prazo: até 24 meses
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a taxa de sobrevivência (sobrevivência/total) durante a estadia na UCI
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até 24 meses
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28-day mortality
Prazo: From randomization to Day 28
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Mortality was calculated on day 28 of treatment
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From randomization to Day 28
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Length of ICU stay
Prazo: up to 28 days
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Time of staying in ICU within 28 days
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up to 28 days
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Infection condition
Prazo: From randomization to Day 28
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Infection condition within 28 days
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From randomization to Day 28
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28-day vasopressor-free days
Prazo: From randomization to Day 28
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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.
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From randomization to Day 28
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28-day ventilator-free days
Prazo: From randomization to Day 28
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Ventilator-free days are defined as the number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization.
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From randomization to Day 28
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Length of hospital stay
Prazo: prior to hospital discharge
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Length of hospital stay
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prior to hospital discharge
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Enteral Nutrition Prescription
Prazo: before treatment,on day 1 of treatment,on day 3 of treatment,on day 7 of treatment
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Enteral Nutrition Prescription was recorded before treatment,on day 1 of treatment,on day 3 of treatment,and on day 7 of treatment.
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before treatment,on day 1 of treatment,on day 3 of treatment,on day 7 of treatment
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Intra-abdominal pressure(mmHg)
Prazo: before treatment,on day 1 of treatment,on day 3 of treatment
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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.
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before treatment,on day 1 of treatment,on day 3 of treatment
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Bowel sounds
Prazo: before treatment,on day 1 of treatment,on day 3 of treatment
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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.
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before treatment,on day 1 of treatment,on day 3 of treatment
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motilin
Prazo: before treatment,on day 1 of treatment,on day 3 of treatment
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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.
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before treatment,on day 1 of treatment,on day 3 of treatment
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gastrin
Prazo: before treatment,on day 1 of treatment,on day 3 of treatment
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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.
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before treatment,on day 1 of treatment,on day 3 of treatment
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vasoactive intestinal peptide
Prazo: before treatment,on day 1 of treatment,on day 3 of treatment
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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.
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before treatment,on day 1 of treatment,on day 3 of treatment
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electrogastroenterography changes:FP(cpm)
Prazo: before treatment,on day 1 of treatment,on day 3 of treatment
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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.
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before treatment,on day 1 of treatment,on day 3 of treatment
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hemoglobin
Prazo: before treatment,on day 1 of treatment,on day 3 of treatment
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Hemoglobin(g/L) are measured at baseline ,Day1, and Day3 as a marker of nutritional condition.
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before treatment,on day 1 of treatment,on day 3 of treatment
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albumin
Prazo: before treatment,on day 1 of treatment,on day 3 of treatment
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Serum albumin levels(g/L) are measured at baseline ,Day1, and Day3 as a marker of nutritional condition.
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before treatment,on day 1 of treatment,on day 3 of treatment
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prealbumin
Prazo: before treatment,on day 1 of treatment,on day 3 of treatment
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Serum prealbumin levels(mg/L) are measured at baseline ,Day1, and Day3 as a marker of nutritional condition.
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before treatment,on day 1 of treatment,on day 3 of treatment
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White blood cell count
Prazo: before treatment, on day 1 of treatment, on day 3 of treatment
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Serum White blood cell count (10^9/L) is measured at baseline ,Day1, and Day3 as a marker of a systemic inflammatory response.
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before treatment, on day 1 of treatment, on day 3 of treatment
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Lymphocyte count
Prazo: before treatment, on day 1 of treatment, on day 3 of treatment
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Serum lymphocyte count (10^9/L) is measured at baseline ,Day1, and Day3 as a marker of a systemic inflammatory response.
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before treatment, on day 1 of treatment, on day 3 of treatment
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C-reactive protein
Prazo: before treatment, on day 1 of treatment, on day 3 of treatment
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Serum C-reactive protein levels(mg/L) are measured at baseline ,Day1, and Day3 as a marker of a systemic inflammatory response.
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before treatment, on day 1 of treatment, on day 3 of treatment
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Procalcitonin
Prazo: before treatment, on day 1 of treatment, on day 3 of treatment
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Serum procalcitonin protein levels(ng/mL) are measured at baseline ,Day1, and Day3 as a marker of a systemic inflammatory response.
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before treatment, on day 1 of treatment, on day 3 of treatment
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electrogastroenterography changes:FC(cpm)
Prazo: 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.
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before treatment, on day 1 of treatment, on day 3 of treatment
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electrogastroenterography changes:AP(uV)
Prazo: 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.
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before treatment, on day 1 of treatment, on day 3 of treatment
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Actual feeding amount
Prazo: before treatment, on day 1 of treatment, on day 3 of treatment, on day 7 of treatment.
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Actual feeding amount (kcal)was recorded before treatment, on day 1 of treatment, on day 3 of treatment, on day 7 of treatment.
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before treatment, on day 1 of treatment, on day 3 of treatment, on day 7 of treatment.
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Intestinal diameter
Prazo: before treatment, on day 1 of treatment, on day 3 of treatment
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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.
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before treatment, on day 1 of treatment, on day 3 of treatment
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Início do estudo
Conclusão Primária (Estimado)
Conclusão Primária
Conclusão do estudo (Estimado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
Outros números de identificação do estudo
- ST36 Acupoint injection
- 2026ZDSYLL103-P01 (Outro identificador: Zhongda Hospital Affiliated to Southeast University)
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