Nanjing University of Traditional Chinese Medicine
Phase
Not applicable
Started
2024-05-10
Last updated
2024-04-23
Condition(s) studied
Acute Respiratory Distress SyndromeSepsis
Investigational drug(s) / intervention(s)
Acupuncture needles
Acupuncture needles: 1. 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.
2. Control group: Placebo needles were 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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Primary outcome measure(s)
Respiratory mechanics indicators 1 — Day 0、day 7 Oxygenation index(P/F)
Respiratory mechanics indicators 2 — Day 0、day 7 Respiratory rate(RR)
Respiratory mechanics indicators 3 — Day 0、day 7 Driving pressure(DP)
Respiratory mechanics indicators 4 — Day 0、day 7 Positive end expiratory pressure(PEEP)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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