Multiple Study of Electroaccpuncture in ARDS

Nanjing University of Traditional Chinese Medicine

Status: Not yet enrolling

Conditions: Acute Respiratory Distress Syndrome; Sepsis

Treatments: Device: Acupuncture needles

Study type: Interventional

Funder types: Other

Identifiers

NCT06278675

SEOVA

Details and patient eligibility

About

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.

Enrollment: 264 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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264 participants in 2 patient groups

Experimental group

Experimental group

Description:

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.

Treatment:

Device: Acupuncture needles

Control group

No Intervention group

Description:

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.