Using electroacupuncture to help patients with severe stroke wean off ventilators
Electroacupuncture to Assist Ventilator Weaning in Severe Stroke: a Randomized, Sham-controlled Pilot Study
This study is testing if electroacupuncture can help patients with severe strokes who are on ventilators breathe on their own again.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04816201 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of electroacupuncture in assisting patients with severe stroke to wean off mechanical ventilation. It focuses on patients who have developed respiratory muscle atrophy and diaphragmatic dysfunction due to prolonged ventilation. A total of 100 eligible patients will be randomly assigned to receive either electroacupuncture or sham treatment daily until they successfully wean off the ventilator, with a maximum duration of 21 days. The primary outcome measured will be the duration of ventilation within this period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 who have experienced a stroke within the last 7 days and require mechanical ventilation.
Not a fit: Patients who are expected to be ventilated for less than 24 hours or have been on a ventilator for more than 72 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the weaning process from ventilators for patients with severe stroke.
How similar studies have performed: While the use of electroacupuncture in this context is relatively novel, similar studies have shown promising results in improving respiratory function.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong
- The Second Affiliated Hospital of Guangzhou University of Chinese Medicine — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Fang Yuan, PhD
- Email: yuanfang@gzucm.edu.cn
- Phone: +86-20-81887233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.