Non-Invasive Transcutaneous Repetitive Phrenic Nerve Stimulation Assessment in Critically Ill Patients Under Mechanical Ventilation - Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Maximum diaphragm thickness during phrenic nerve repetitive stimulation
研究概览
简要总结
Subjects: Patients aged 19 and older who are currently in the ICU and undergoing invasive mechanical ventilation.
Methods: The study involves performing non-invasive repetitive phrenic nerve stimulation in ICU patients on mechanical ventilation.
Stimulation protocol: The intensity and position of phrenic nerve stimulation were individualized. The frequency was set to 10Hz, 15Hz, and 20Hz. The duration of stimulation was adjusted according to the set inspiration time of mechanical ventilation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 19 and older who are admitted to the ICU at Seoul National University Hospital
- •Patients receiving invasive mechanical ventilation (via endotracheal tube or tracheostomy)
- •Patients who have been on invasive mechanical ventilation (via endotracheal tube or tracheostomy) for more than 48 hours
- •Patients who have listened to and understood the explanation of the purpose and procedures of the study and have voluntarily agreed to participate. In cases where the patient has impaired consciousness or cognitive function and is unable to consent, the patient's legal representative has agreed to the patient's participation in the study.
排除标准
- •Patients with implanted or externally applied electrical devices (such as pacemakers, defibrillators, implantable defibrillators, vagus nerve stimulators, spinal cord stimulators, gastric stimulators, diaphragm stimulators, etc.)
- •Patients with a history of neck tumors, cervical spine instability, or neck surgery
- •Patients with internal jugular vein catheters, infections, or inflammatory signs at the electrical stimulation site, making percutaneous phrenic nerve access impossible
- •Patients with neurological or neuromuscular diseases that significantly affect respiratory muscle function
- •Patients currently receiving neuromuscular blocking agents
- •Patients already diagnosed with or suspected of having phrenic nerve paralysis
- •Patients with elevated hemidiaphragm observed on chest X-ray
- •Patients with pleural effusion occupying more than one-third of the pleural space or pneumothorax requiring chest tube insertion, as seen on chest X-ray
- •Patients who are confirmed or presumed to be pregnant
- •Patients with a body mass index (BMI) ≥ 40
- •Patients for whom life-sustaining treatment has been decided to be withdrawn and who have no plans for active treatment
结局指标
主要结局
Maximum diaphragm thickness during phrenic nerve repetitive stimulation
时间窗: Measured one time between 48 hours after intubation and before extubation.
Maximum diaphragm thickness (mm)
Change in diaphragm thickness before and during phrenic nerve repetitive stimulation
时间窗: Measured one time between 48 hours after intubation and before extubation.
Change of diaphragm thickness (mm)
次要结局
- Area of the phrenic nerve compound motor action potential during phrenic nerve repetitive stimulation(Measured one time between 48 hours after intubation and before extubation.)
- Amplitude of the phrenic nerve compound motor action potential during phrenic nerve repetitive stimulation(Measured one time between 48 hours after intubation and before extubation.)
研究者
Sung Eun Hyun
Assistant professor (MD, PhD)
Seoul National University Hospital