Multiple Study of Electroaccpuncture in ARDS
- Conditions
- SepsisAcute Respiratory Distress Syndrome
- Interventions
- Device: Acupuncture needles
- Registration Number
- NCT06278675
- Lead Sponsor
- Nanjing University of Traditional Chinese Medicine
- Brief Summary
In order to clarify the clinical efficacy of electroacupuncture on inhibiting systemic inflammatory response, improving respiratory mechanics parameters and prognosis in patients with sepsis-related ARDS.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 264
- Meet the diagnostic criteria of the Surviving Sepsis Campaign: Updated International Guidelines for the Treatment of Sepsis and Septic Shock 2021
- Meet the diagnostic criteria of the European Society of Critical Care Medicine (ESICM) Guidelines for Acute Respiratory Distress Syndrome: Definition, Phenotype and Respiratory Support Strategies
- Age >18 years
- Expected duration of mechanical ventilation>48 hours
- Expected ICU stay of more than 7 days
- Signed informed consent.
- Participated in other clinical trials
- Pregnant, lactating or miscarriage
- Patients with disseminated tumors or tumors receiving chemotherapy and other special treatments
- Alcohol abuse
- Severe cardiovascular, brain, liver, kidney, psychiatric diseases, diabetes, multiple system atrophy, cauda equina injury or myelopathy
- Systolic blood pressure < 90mmHg within 2 hours before the start of the study
- Severe burns or severe skin diseases
- Pacemaker placement, metal allergy or severe needle sickness
- Abnormal coagulation function
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Acupuncture needles Experimental group: Sterile stainless steel needle electroacupuncture treatment was applied, and the acupuncture points were as follows: bilateral Zusanli (ST36), Neiguan (PC6), Hegu (LI4), Shaoshang (LU11), and Feng Long (ST40). 1 time a day, 30 minutes each time, for 7 days.
- Primary Outcome Measures
Name Time Method Respiratory mechanics indicators 1 Day 0、day 7 Oxygenation index(P/F)
Respiratory mechanics indicators 3 Day 0、day 7 Driving pressure(DP)
Respiratory mechanics indicators 2 Day 0、day 7 Respiratory rate(RR)
Respiratory mechanics indicators 4 Day 0、day 7 Positive end expiratory pressure(PEEP)
Respiratory mechanics indicators 5 Day 0、day 7 Mechanical ventilation days(MV days)
Respiratory mechanics indicators 6 Day 0、day 7 Mechanical ventilation free days(MV free days)
Respiratory mechanics indicators 7 Day 0、day 7 Extubation situation
- Secondary Outcome Measures
Name Time Method All-cause mortality to day 60 Up to 60 days The prognosis of patients on the 60th days will be counted.
ECMO applications Day 0 to day 7 The duration of extracorporeal membrane oxygenation will be recorded.
Sedation and analgesia Day 0、day 7 RASS score
Analgesic drug use Day 0、day 7 The dose and duration of analgesic medication will be recorded.
Inflammatory factors Day 0、day 7 IL-1β、IL-6、IL-2、IL-4、IL-5、IL-8、IL-10、IL-17、IL-12、 IFN-γ、IFN-α、TNF-α.
All-cause mortality to day 28 Up to 28 days The prognosis of patients on the 28th days will be counted.
Vasoactive drugs applications Day 0 to day 7 The duration of vasoactive drug use will be recorded.
CRRT applications Day 0 to day 7 The duration of continuous renal replacement therapy will be recorded.
ICU-free days 2 year The prognosis of patients ICU length of stay will be counted.
Hospital-free days 2 year The prognosis of patients total length of stay will be counted.
CD4、CD8、CD4/CD8 Day 0、day 7 Flow cytometry will be used to detect serum CD4, CD8 and CD4/CD8 levels.
Sedative drug use Day 0、day 7 The dose and duration of sedative medication will be recorded.
Trial Locations
- Locations (1)
Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine
🇨🇳Nanjing, Jiangsu, China