Respiratory FailureEA-ICUAWNCT02204215
Electric Acupuncture for ICU-acquired Weakness in Mechanical Ventilation Patients
A study testing electric acupuncture and conservative in people with Respiratory Failure and Sepsis, run by Jiangsu Province Hospital of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Failure, Sepsis, Multiple Organ Dysfunction Syndrome
- What is being tested?
- electric acupuncture and conservative
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of sepsis or multiple organ dysfunction syndrome
- Within 48 hours from the initiation of mechanical ventilation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Intensive Care Unit, Jiangsu Province Hospital of TCM
Nanjing, Jiangsu, 210000
About this study
Official title: Phase 1 Study of Electric Acupuncture for ICU-acquired Weakness in Mechanical Ventilation Patients With Sepsis/Multiple Organ Dysfunction Syndrome
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.
Read the 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.
- Being tested
- electric acupuncture, conservative
- Keywords
- Weakness, Mechanical Ventilation, Acupuncture Therapy
- Medical subject headings
- Respiratory Insufficiency, Sepsis, Multiple Organ Failure, Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electric acupunctureDevice
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.
conservativeOther
General treatment, without electric acupuncture, include passive range-of-motion exercise，q2H turning，minimizing the use of sedation, etc.
| Study group | Role | What they receive |
|---|---|---|
| electric acupuncture & conservative | Experimental | Electric acupuncture therapy on four limbs 30 min each time, twice per day; or conservative treatment without electric acupuncture. Receives: Device: electric acupuncture; Other: conservative |
What is being measured
The primary outcome is the main question the study is designed to answer.
strength related parameters
muscle force, arm circumference, skin fold thickness
Measured: Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks
Secondary outcomes (4)
mechanical ventilation duration
the time span from the beginning of mechanical ventilation, till the weaning of mechanical ventilation
Measured: 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
Measured: 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.
Measured: 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
Measured: Participants will be followed until the date of discharge from the ICU, an expected average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wangxing, Jiangsu Province Hospital of Traditional Chinese Medicine
- Investigators
- Xing Wang, M.D., Principal investigator, Director of Intensive Care Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204215
- Sponsor's protocol ID
- EA-ICUAW
- Acronym
- EA-ICUAW
- Status last verified
- Jul 2014
- First submitted
- 25 Jul 2014
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Electric Acupuncture for ICU-acquired Weakness in Mechanical Ventilation Patients With Sepsis/Multiple Organ Dysfunction Syndrome
- ClinicalTrials.gov ID
- NCT02204215
- Acronym / sponsor ID
- EA-ICUAW / EA-ICUAW
- Keywords
- Weakness, Mechanical Ventilation, Acupuncture Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jiangsu Province Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| electric acupuncture & conservative | Experimental | Device: electric acupuncture, Other: conservativeElectric acupuncture therapy on four limbs 30 min each time, twice per day; or conservative treatment without electric acupuncture. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of sepsis or multiple organ dysfunction syndrome
- Within 48 hours from the initiation of mechanical ventilation
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electric acupunctureElectric 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. | Device | electric acupuncture & conservative |
| conservativeGeneral treatment, without electric acupuncture, include passive range-of-motion exercise，q2H turning，minimizing the use of sedation, etc. | Other | electric acupuncture & conservative |
Primary outcome
strength related parameters
Time frame: 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
4 secondary outcomes
mechanical ventilation duration
Time frame: Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks
28-day mortality
Time frame: Participants will be followed until the 28th day after mechanical ventilation
number of participants with adverse events of electric acupuncture
Time frame: Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks
ICU duration
Time frame: Participants will be followed until the date of discharge from the ICU, an expected average of 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xing Wang, M.D. principal investigator
Director of Intensive Care Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electric acupuncture and conservative in people with Respiratory Failure and Sepsis, run by Jiangsu Province Hospital of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
strength related parameters (time frame: Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2014.