Multiple Study of Electroaccpuncture in ARDS

NCT06278675 | Not Yet Recruiting

• 1 other identifier: SEOVA
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Respiratory Distress Syndrome; Sepsis

Outcome Measures

Primary Outcomes (7)

• Respiratory mechanics indicators 1

  Oxygenation index(P/F)

  Day 0、day 7

• Respiratory mechanics indicators 2

  Respiratory rate(RR)

  Day 0、day 7

• Respiratory mechanics indicators 3

  Driving pressure(DP)

  Day 0、day 7

• Respiratory mechanics indicators 4

  Positive end expiratory pressure(PEEP)

  Day 0、day 7

• Respiratory mechanics indicators 5

  Mechanical ventilation days(MV days)

  Day 0、day 7

• Respiratory mechanics indicators 6

  Mechanical ventilation free days(MV free days)

  Day 0、day 7

• Respiratory mechanics indicators 7

  Extubation situation

  Day 0、day 7

Secondary Outcomes (12)

• Sedation and analgesia

  Day 0、day 7

• Sedative drug use

  Day 0、day 7

• Analgesic drug use

  Day 0、day 7

• Inflammatory factors

  Day 0、day 7

• CD4、CD8、CD4/CD8

  Day 0、day 7

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Acupuncture needles 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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing University of Traditional Chinese Medicine: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Sepsis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jun Lu, Doctor

  Jiangsu Province Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Lu, Doctor

CONTACT

+86 13813865758; lujun@njucm.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 26, 2024
• Study Start: May 10, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)