Electroacupuncture to Assist Ventilator Weaning in Severe Stroke

Guangzhou University of Chinese Medicine

Status: Enrolling

Conditions: Severe Stroke; Electroacupuncture

Treatments: Other: Electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04816201

ZF2021-035

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Electroacupuncture

Experimental group

Description:

Participants in the electroacupuncture group received acupuncture at Xuanji (CV21), Danzhong (CV27), Qihai (CV06), Guanyuan (CV04), and bilateral Liangmen (ST21) and Zusanli (ST36). After skin disinfection, sterile adhesive pads were placed on these acupoints, and acupuncture needles were inserted through the adhesive pads approximately 50 to 60 mm into the skin. Paired electrodes from the electroacupuncture apparatus were attached to the needle handles of Xuanji (CV21) and Danzhong (CV27), Qihai (CV06), Guanyuan (CV04), bilateral Liangmen (ST21), and bilateral Zusanli (ST36). The electroacupuncture stimulation lasted for 30 minutes with an intermittent wave of 50 Hz and a current intensity of 1 to 5mA (preferably with the skin around the acupoints shivering mildly without pain). Participants received 1 treatment session per day until the success of ventilator weaning (up to 21 days).

Treatment:

Other: Electroacupuncture

Sham electroacupuncture

Sham Comparator group

Description:

Participants in the sham electroacupuncture group received sham electroacupuncture with a pragmatic placebo needle on sham acupoints. The sham Xuanji (CV21) point was 1 cun (≈20 mm) above to Xuanji (CV21), the sham Danzhong (CV27) point was 1 cun(≈20mm) above to Danzhong (CV27), the sham Qihai (CV06) point was 1 cun(≈20mm) above to Qihai (CV06), the sham Guanyuan (CV04) point was 1 cun(≈20mm) above to Guanyuan (CV04), the sham Liangmen (ST21) point was 1 cun(≈20mm) lateral to Liangmen (ST21), and the sham Zusanli (ST36) point was 1 cun(≈20mm) lateral to Zusanli (ST36). Procedures, electrode placements, and other treatment settings were the same as in the electroacupuncture group but with no skin penetration or electricity output.

Treatment:

Other: Electroacupuncture