Clinical trial NCT04816201: Electroacupuncture to Assist Ventilator Weaning in Severe Stroke
Official title: Electroacupuncture to Assist Ventilator Weaning in Severe Stroke: a Randomized, Sham-controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Severe Stroke
Electroacupuncture
Keywords: ventilator weaning
severe stroke
electroacupuncture
Lead sponsor: The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: ventilation duration
timeFrame: within 21 days after enrollment
Secondary outcomes:
measure: rate of successful ventilator weaning
timeFrame: within 21 days after enrollment
measure: diaphragm muscle thickness
timeFrame: on day 7, day 14 and day 21
measure: diaphragm thickening fraction
timeFrame: on day 7, day 14 and day 21
measure: diaphragm excursion
timeFrame: on day 7, day 14 and day 21
measure: rate of death
timeFrame: within 21 days after enrollment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
Study officials:
affiliation: The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
name: Lixin Wang, PhD
role: STUDY_DIRECTOR
References:
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citation: Bellani G, Bronco A, Arrigoni Marocco S, Pozzi M, Sala V, Eronia N, Villa G, Foti G, Tagliabue G, Eger M, Pesenti A. Measurement of Diaphragmatic Electrical Activity by Surface Electromyography in Intubated Subjects and Its Relationship With Inspiratory Effort. Respir Care. 2018 Nov;63(11):1341-1349. doi: 10.4187/respcare.06176.
citation: McCaughey EJ, Jonkman AH, Boswell-Ruys CL, McBain RA, Bye EA, Hudson AL, Collins DW, Heunks LMA, McLachlan AJ, Gandevia SC, Butler JE. Abdominal functional electrical stimulation to assist ventilator weaning in critical illness: a double-blinded, randomised, sham-controlled pilot study. Crit Care. 2019 Jul 24;23(1):261. doi: 10.1186/s13054-019-2544-0.
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