Electric Acupuncture for ICU-acquired Weakness in Mechanical Ventilation Patients

NCT ID: NCT02204215

Last Updated: 2014-07-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-12-31

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.

Conditions

Respiratory Failure; Sepsis; Multiple Organ Dysfunction Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

electric acupuncture & conservative

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

Group Type: EXPERIMENTAL

electric acupuncture

Intervention Type: DEVICE

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.

conservative

Intervention Type: OTHER

General treatment, without electric acupuncture, include passive range-of-motion exercise，q2H turning，minimizing the use of sedation, etc.

Interventions

electric acupuncture

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: DEVICE

conservative

General treatment, without electric acupuncture, include passive range-of-motion exercise，q2H turning，minimizing the use of sedation, etc.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Province Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Wangxing

Director of Intensive Care Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xing Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Director of Intensive Care Unit

Locations

Department of Intensive Care Unit, Jiangsu Province Hospital of TCM

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

EA-ICUAW

Identifier Type: -

Identifier Source: org_study_id