This multicenter, single-arm exploratory IIT evaluates epidural spinal cord electrical stimulation (ESCES) in 20 adults with C1-C5 SCI and respiratory failure. Participants receive ESCES plus standard care; electrodes are implanted at C3-C5 with daily individualized stimulation. Primary outcomes: Edi peak, change of Edi peak and frequency. Secondary: tidal volume, maximal inspiratory pressure, NVE, NME, diaphragm ultrasound, cough strength, 90-day ventilator-free days, ICU stay, and survival. This is the first systematic ESCES study for SCI-related respiratory failure, aiming to provide preliminary safety/efficacy data for future RCTs.
Inclusion Criteria:
Age between 18 and 75 years, with BMI <30 kg/m².
Cervical SCI involving levels C1-C5 for at least 2 weeks.
Respiratory failure defined by one or more of the following:
Maximum inspiratory pressure (MIP) >-15 cmHâ‚‚O.
Judged by the treating physician to be unable to tolerate continuous ventilator weaning for ≥48 hours due to SCI.
Written informed consent provided by the participant or legally authorized representative.
Exclusion Criteria:
afei0312@163.com15950565786
jianfengxie01@seu.edu.cn
Nanjing, Jiangsu 210009, China
liwenb1@126.com15250963911
afei0312@163.com15950565786
jianfengxie01@seu.edu.cn
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