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Electric Acupuncture for ICU-acquired Weakness in Mechanical Ventilation Patients (EA-ICUAW)

Primary Purpose

Respiratory Failure, Sepsis, Multiple Organ Dysfunction Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
electric acupuncture
conservative
Sponsored by
Jiangsu Province Hospital of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring Weakness, Mechanical Ventilation, Acupuncture Therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Intensive Care Unit, Jiangsu Province Hospital of TCM

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

electric acupuncture & conservative

Arm Description

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

Outcomes

Primary Outcome Measures

strength related parameters
muscle force, arm circumference, skin fold thickness

Secondary Outcome Measures

mechanical ventilation duration
the time span from the beginning of mechanical ventilation, till the weaning of mechanical ventilation
28-day mortality
the mortality till 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.
ICU duration
the time span from the beginning of mechanical ventilation, till the date of discharge from the ICU

Full Information

First Posted
July 25, 2014
Last Updated
July 28, 2014
Sponsor
Jiangsu Province Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02204215
Brief Title
Electric Acupuncture for ICU-acquired Weakness in Mechanical Ventilation Patients
Acronym
EA-ICUAW
Official Title
Phase 1 Study of Electric Acupuncture for ICU-acquired Weakness in Mechanical Ventilation Patients With Sepsis/Multiple Organ Dysfunction Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jiangsu Province Hospital of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Sepsis, Multiple Organ Dysfunction Syndrome
Keywords
Weakness, Mechanical Ventilation, Acupuncture Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
electric acupuncture & conservative
Arm Type
Experimental
Arm Description
Electric acupuncture therapy on four limbs 30 min each time, twice per day; or conservative treatment without electric acupuncture.
Intervention Type
Device
Intervention Name(s)
electric acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
conservative
Intervention Description
General treatment, without electric acupuncture, include passive range-of-motion exercise，q2H turning，minimizing the use of sedation, etc.
Primary Outcome Measure Information:
Title
strength related parameters
Description
muscle force, arm circumference, skin fold thickness
Time Frame
Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks
Secondary Outcome Measure Information:
Title
mechanical ventilation duration
Description
the time span from the beginning of mechanical ventilation, till the weaning of mechanical ventilation
Time Frame
Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks
Title
28-day mortality
Description
the mortality till the 28th day after mechanical ventilation
Time Frame
Participants will be followed until the 28th day after mechanical ventilation
Title
number of participants with adverse events of electric acupuncture
Description
the adverse enents include fainting, infection, bleeding, viscera damage, and so on.
Time Frame
Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks
Title
ICU duration
Description
the time span from the beginning of mechanical ventilation, till the date of discharge from the ICU
Time Frame
Participants will be followed until the date of discharge from the ICU, an expected average of 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xing Wang, M.D.
Organizational Affiliation
Director of Intensive Care Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Intensive Care Unit, Jiangsu Province Hospital of TCM
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China

12. IPD Sharing Statement

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Electric Acupuncture for ICU-acquired Weakness in Mechanical Ventilation Patients

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