Multiple Study of Electroaccpuncture in ARDS

April 22, 2024 updated by: Jun Lu, MD, Nanjing University of Traditional Chinese Medicine

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
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.
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, for 7 days.
No Intervention: Control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory mechanics indicators 1
Time Frame: Day 0、day 7
Oxygenation index(P/F)
Day 0、day 7
Respiratory mechanics indicators 2
Time Frame: Day 0、day 7
Respiratory rate(RR)
Day 0、day 7
Respiratory mechanics indicators 3
Time Frame: Day 0、day 7
Driving pressure(DP)
Day 0、day 7
Respiratory mechanics indicators 4
Time Frame: Day 0、day 7
Positive end expiratory pressure(PEEP)
Day 0、day 7
Respiratory mechanics indicators 5
Time Frame: Day 0、day 7
Mechanical ventilation days(MV days)
Day 0、day 7
Respiratory mechanics indicators 6
Time Frame: Day 0、day 7
Mechanical ventilation free days(MV free days)
Day 0、day 7
Respiratory mechanics indicators 7
Time Frame: Day 0、day 7
Extubation situation
Day 0、day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sedation and analgesia
Time Frame: Day 0、day 7
RASS score
Day 0、day 7
Sedative drug use
Time Frame: Day 0、day 7
The dose and duration of sedative medication will be recorded.
Day 0、day 7
Analgesic drug use
Time Frame: Day 0、day 7
The dose and duration of analgesic medication will be recorded.
Day 0、day 7
Inflammatory factors
Time Frame: 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.
Day 0、day 7
CD4、CD8、CD4/CD8
Time Frame: Day 0、day 7
Flow cytometry will be used to detect serum CD4, CD8 and CD4/CD8 levels.
Day 0、day 7
Vasoactive drugs applications
Time Frame: Day 0 to day 7
The duration of vasoactive drug use will be recorded.
Day 0 to day 7
CRRT applications
Time Frame: Day 0 to day 7
The duration of continuous renal replacement therapy will be recorded.
Day 0 to day 7
ECMO applications
Time Frame: Day 0 to day 7
The duration of extracorporeal membrane oxygenation will be recorded.
Day 0 to day 7
All-cause mortality to day 28
Time Frame: Up to 28 days
The prognosis of patients on the 28th days will be counted.
Up to 28 days
All-cause mortality to day 60
Time Frame: Up to 60 days
The prognosis of patients on the 60th days will be counted.
Up to 60 days
ICU-free days
Time Frame: 2 year
The prognosis of patients ICU length of stay will be counted.
2 year
Hospital-free days
Time Frame: 2 year
The prognosis of patients total length of stay will be counted.
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing University of Traditional Chinese Medicine

Investigators

  • Principal Investigator: Jun Lu, Doctor, Jiangsu Province Hospital of Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 10, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

February 19, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEOVA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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