Multiple Study of Electroaccpuncture in ARDS

NCT ID: NCT06278675

Last Updated: 2024-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-10

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Acute Respiratory Distress Syndrome Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Acupuncture needles

Intervention Type DEVICE

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jun Lu, MD

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jun Lu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Province Hospital of Traditional Chinese Medicine

Locations

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Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine

Nanjing, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Jun Lu, Doctor

Role: CONTACT

+86 13813865758

Facility Contacts

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Jun Lu, Doctor

Role: primary

+86 13813865758

Other Identifiers

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SEOVA

Identifier Type: -

Identifier Source: org_study_id

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