Electric Acupuncture for ICU-acquired Weakness in Mechanical Ventilation Patients

Study Overview
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Brief Summary
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Intensive care unit acquired weakness (ICU-AW) is common and dramatically affect recovery. The purpose of this study is to determine whether electric acupuncture therapy is effective in the treatment of ICU-AW especially in the patients receiving mechanical ventilation with sepsis or multiorgan system failure.

Detailed Description
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The principle of acupuncture is to produce bioelectric current, as a consequence, to invigorate the circulation, promote tissue regeneration, relieve pain, enhance the immune function, etc. And electric acupuncture can stimulate bioelectricity activities at acupoints, out of reach for ordinary acupuncture effect, especially in the fields of nerve/muscle recovery and regeneration.

Official Title
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Phase 1 Study of Electric Acupuncture for ICU-acquired Weakness in Mechanical Ventilation Patients With Sepsis/Multiple Organ Dysfunction Syndrome

Conditions
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Respiratory Failure, Sepsis, Multiple Organ Dysfunction Syndrome

Intervention / Treatment
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* Device: electric acupuncture
* Other: conservative


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of sepsis or multiple organ dysfunction syndrome Within 48 hours from the initiation of mechanical ventilation Exclusion Criteria: Pregnant patients Neuromuscular disease or cerebrovascular accident With temporary or permanent pacemaker Need to use neuromuscular blocking agents Inactivity for more than 5 days before ICU admission

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electric acupuncture & conservative<br>Electric acupuncture therapy on four limbs 30 min each time, twice per day; or conservative treatment without electric acupuncture. | Device: electric acupuncture<br>* Electric acupuncture therapy was made on LI4, LI11, ST36, and ST41 on four limbs for each patient, 30 min for each time, twice per day. Starting from the beginning of mechanical ventilation, to the weaning of the mechanical ventilation.<br>Other: conservative<br>* General treatment, without electric acupuncture, include passive range-of-motion exercise，q2H turning，minimizing the use of sedation, etc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| strength related parameters | muscle force, arm circumference, skin fold thickness | Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mechanical ventilation duration | the time span from the beginning of mechanical ventilation, till the weaning of mechanical ventilation | Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks | 
| 28-day mortality | the mortality till the 28th day after mechanical ventilation | Participants will be followed until the 28th day after mechanical ventilation | 
| number of participants with adverse events of electric acupuncture | the adverse enents include fainting, infection, bleeding, viscera damage, and so on. | Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks | 
| ICU duration | the time span from the beginning of mechanical ventilation, till the date of discharge from the ICU | Participants will be followed until the date of discharge from the ICU, an expected average of 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weakness, Mechanical Ventilation, Acupuncture Therapy