Electroacupuncture to Assist Ventilator Weaning in Severe Stroke

Electroacupuncture to Assist Ventilator Weaning in Severe Stroke: a Randomized, Sham-controlled Pilot Study

The purpose of this study is to evaluate the efficacy of electroacupuncture in assisting ventilator weaning in patients with severe stroke

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.

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.