Multiple Study of Electroaccpuncture in ARDS
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanjing University of Traditional Chinese Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Participated in other clinical trials
Pregnant, lactating or miscarriage
Patients with disseminated tumors or tumors receiving chemotherapy and other special treatments
Alcohol abuse
Trial design
Design model
Parallel
Treatments tested in this trial
Acupuncture needles
Device1. 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.
Treatment groups
264 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Respiratory mechanics indicators 1
Oxygenation index(P/F)
Time frame
Day 0、day 72
Respiratory mechanics indicators 2
Respiratory rate(RR)
Time frame
Day 0、day 73
Respiratory mechanics indicators 3
Driving pressure(DP)
Time frame
Day 0、day 74
Respiratory mechanics indicators 4
Positive end expiratory pressure(PEEP)
Time frame
Day 0、day 7Secondary outcomes
1
Sedation and analgesia
RASS score
Time frame
Day 0、day 72
Sedative drug use
The dose and duration of sedative medication will be recorded.
Time frame
Day 0、day 73
Analgesic drug use
The dose and duration of analgesic medication will be recorded.
Time frame
Day 0、day 74
Inflammatory factors
IL-1β、IL-6、IL-2、IL-4、IL-5、IL-8、IL-10、IL-17、IL-12、 IFN-γ、IFN-α、TNF-α.
Time frame
Day 0、day 7Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: