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Not yet recruiting NCT06278675

Multiple Study of Electroaccpuncture in ARDS

No phase Interventional Acute Respiratory Distress Syndrome Sepsis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acupuncture needles.
Who it may be relevant to
Registry conditions: Acute Respiratory Distress Syndrome, Sepsis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Multicenter Clinical Study on the Effect of Electroacupuncture on the Mechanical Ventilation Strategy in Patients With Sepsis-related ARDS

Overview

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.

Interventions

  • Device 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

Primary outcome measures

  • Respiratory mechanics indicators 1 [Time frame: Day 0、day 7]
  • Respiratory mechanics indicators 2 [Time frame: Day 0、day 7]
  • Respiratory mechanics indicators 3 [Time frame: Day 0、day 7]
  • Respiratory mechanics indicators 4 [Time frame: Day 0、day 7]
  • Respiratory mechanics indicators 5 [Time frame: Day 0、day 7]
  • Respiratory mechanics indicators 6 [Time frame: Day 0、day 7]
  • Respiratory mechanics indicators 7 [Time frame: Day 0、day 7]
Secondary outcome measures (12)
  • Sedation and analgesia [Time frame: Day 0、day 7]
  • Sedative drug use [Time frame: Day 0、day 7]
  • Analgesic drug use [Time frame: Day 0、day 7]
  • Inflammatory factors [Time frame: Day 0、day 7]
  • CD4、CD8、CD4/CD8 [Time frame: Day 0、day 7]
  • Vasoactive drugs applications [Time frame: Day 0 to day 7]
  • CRRT applications [Time frame: Day 0 to day 7]
  • ECMO applications [Time frame: Day 0 to day 7]
  • All-cause mortality to day 28 [Time frame: Up to 28 days]
  • All-cause mortality to day 60 [Time frame: Up to 60 days]
  • ICU-free days [Time frame: 2 year]
  • Hospital-free days [Time frame: 2 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital o — Nanjing

Identifiers

NCT: NCT06278675 · SEOVA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗