Electroacupuncture, Severe Stroke
Conditions
Keywords
ventilator weaning, severe stroke, electroacupuncture
Brief summary
The purpose of this study is to evaluate the efficacy of electroacupuncture in assisting ventilator weaning in patients with severe stroke
Detailed description
Disuse atrophy of the major respiratory muscles and diaphragmatic dysfunction often develop during mechanical ventilation, and cause difficulties in ventilator weaning. Electroacupuncture was indicated to promote activities of diaphragm and improve diaphragmatic function. Our aim is to evaluate the efficacy of electroacupuncture in assisting ventilator weaning in patients with severe stroke. 100 eligible patients will be randomly assigned to receive electroacupuncture or sham electroacupuncture treatment one session per day until the success of ventilator weaning (up to 21 days). The primay outcome is the ventilation duration within 21 days after enrollment.
Interventions
OTHERElectroacupuncture
Electroacupuncture at Xuanji (CV21), Danzhong (CV27), Qihai (CV06), Guanyuan (CV04), and bilateral Liangmen (ST21) and Zusanli (ST36).
Sponsors
The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. age ≥ 18 years and ≤ 75 years ; 2. within 7 days after the onset of stroke (ischemic or hemorrhagic), confirmed by a computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain; 3. GCS on admission ≤ 12 or NIHSS on admission ≥ 11 or APACHEⅡ ≥ 15; 4. received mechanical ventilation; 5. written informed consent is able to be obtained directly from the patient or an appropriate surrogate, based on local ethics committee recommendations.
Exclusion criteria
1. expected to be ventilated for \< 24 h; 2. already ventilated for \> 72 h; 3. GCS \<5; 4. with unstable vital signs and requiring the use of vasoactive agents; 5. concomitant medical illness that would interfere with the outcome assessments and/or follow-up; 6. had spinal cord injury above T8 level, or lower motor neuron impairment, or neuromuscular junction impairment，or chest wall deformities, or chest wall injuries within 6 months, or chest or abdominal surgery within 4 week, or were pregnant; 7. had acute skin injury on the selected acupoints; 8. currently participating in other investigational trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ventilation duration | within 21 days after enrollment | hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of successful ventilator weaning | within 21 days after enrollment | percentage |
| diaphragm muscle thickness | on day 7, day 14 and day 21 | mm |
| diaphragm thickening fraction | on day 7, day 14 and day 21 | percentage |
| diaphragm excursion | on day 7, day 14 and day 21 | mm |
| rate of death | within 21 days after enrollment | percentage |
Countries
China
Contacts
Primary ContactFang Yuan, PhD
Outcome results
None listed