Electric Acupuncture for ICU-acquired Weakness in Mechanical Ventilation Patients

Not Applicable

• Conditions: Multiple Organ Dysfunction Syndrome; Respiratory Failure; Sepsis
• Interventions: Device: electric acupuncture; Other: conservative

• Registration Number: NCT02204215
• Lead Sponsor: Jiangsu Province Hospital of Traditional Chinese Medicine

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-01
• Status Verified: 2014-07
• Study First Submitted: 2014-07-25
• Study First Submitted QC: 2014-07-28
• Last Update Submitted: 2014-07-28
• Study First Posted: 2014-07-30
• Last Update Posted: 2014-07-30
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
electric acupuncture & conservative	electric acupuncture	Electric acupuncture therapy on four limbs 30 min each time, twice per day; or conservative treatment without electric acupuncture.
electric acupuncture & conservative	conservative	Electric acupuncture therapy on four limbs 30 min each time, twice per day; or conservative treatment without electric acupuncture.

Primary Outcome Measures

Name	Time	Method
strength related parameters	Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks	muscle force, arm circumference, skin fold thickness

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Intensive Care Unit, Jiangsu Province Hospital of TCM; 🇨🇳 Nanjing, Jiangsu, China