Transcutaneous Spinal Cord Stimulation to Improve Respiratory Function and Shorten Ventilator Dependence in Patients with ARDS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Recording of significant stimulation-induced adverse events (AE)
研究概览
简要总结
This is an early phase, proof-of-concept clinical trial assessing the safety and feasibility of non-invasive spinal cord stimulation to prevent respiratory muscle atrophy in mechanically ventilated ARDS patients. The investigators will recruit 10 elective surgery patients (surgery cohort) and 10 ARDS patients (ARDS cohort) for this study. A non-invasive, alpha-prototype Restore Technology stimulator using hydrogel surface electrodes will be used to stimulate the spinal cord at the cervical or thoracic level.
详细描述
Stimulation will be conducted in closed-loop fashion at the start of inspiratory cycle. Signal from a chest belt will be used to synchronize stimulation with ventilator and prevent interference with ventilator (see Protection of Human Subjects). Prior to treatment stimulation, mapping will be conducted at 1 Hz with electrodes placed in locations identified to be optimal in the surgery cohort. Assessment of evoked EMG responses from respiratory muscles will be conducted. Once this electrode configuration is confirmed as effective (capable of evoking EMG activity), stimulation with this configuration will be applied for treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18-85 years;
- •Intubated with confirmed diagnosis of ARDS (by Berlin Criteria: acute onset within one week of known insult, bilateral airspace opacities not fully explained by pleural effusions, atelectasis, and/or nodules, respiratory failure not explained by heart failure or fluid overload, PaO2/FiO2 ratio < 300); or identified as a patient admitted to the intensive care unit (ICU) after non-cardiac surgery;
- •Able to provide informed consent or available next of kin able to provide informed consent;
- •Have intact chest/lung, upper and lower extremity anatomy;
- •The neuromuscular connections between the spinal cord, diaphragm, and intercostal muscles are intact;
- •Enrollment of subject within 48 hours of intubation;
- •Able to induce evoked response of diaphragm muscle by spinal cord TES.
排除标准
- •Phrenic nerve or diaphragm pacer;
- •History of seizure disorder or on anti-epileptic medication for the treatment of seizures;
- •Compromised skin in back (neck, upper and lower back);
- •Implanted devices: cardiac pacemakers, implanted defibrillators, implanted neurostimulators, phrenic nerve pacers;
- •BMI greater than or equal to 35;
- •Pharmacological paralysis/neuromuscular blockade*.
结局指标
主要结局
Recording of significant stimulation-induced adverse events (AE)
时间窗: 1-48 months
Although unlikely, we will record and monitor the number of stimulation-induced adverse events per case and per cohort. Our goal is to have an overall AE rate of less than 10% per cohort.
次要结局
- Measurement of respiratory pressure(1-48 months)
- Recording of total ventilation time(1-48 months)
- Assessment of respiratory tidal volume(1-48 months)
- Measurement of diaphragm thickness(1-48 months)
- Measurement of ventilator weaning time(1-48 months)
- Assessment of diaphragm and respiratory muscle EMG amplitudes(1-48 months)
研究者
Daniel Lu, MD, PhD
Professor, Neurosurgery
University of California, Los Angeles