Electromagnetic Stimulation of the Phrenic Nerve to Generate Contraction of the Diaphragm in Anesthetized and Intubated Patients - a Proof-of-concept Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Tidal volume generated by electromagentical stimulation of the phrenic nerve (ml)
研究概览
简要总结
Ventilator-induced diaphragmatic dysfunction is a common issue in critically ill patients. Muscle stimulation has shown to have beneficial effects in muscle groups on the extremities. A non-invasive way to stimulate the diaphragm would be the electromagnetic stimulation but it is currently unclear if that is feasible.
In this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction leading to an inspiration with a sufficient tidal volume via an external electromagnetic stimulation of the phrenic nerve.
详细描述
During the time of first spontaneous breathing trial 60% of mechanically ventilated patients present with diaphragmatic weakness or also know as ventilator-induced diaphragmatic dysfunction (VIDD). The damage to the diaphragm in terms of muscle atrophy has been shown as early as 12 hours after initiation of mechanical ventilation. Recently, a correlation between diaphragmatic atrophy and mortality could be established.
Induction of diaphragmatic contractions via stimulation of the phrenic nerve would be a possible method to prevent or treat VIDD. A possible modality would be the non-invasive electromagnetic stimulation but feasibility has not been established.
In this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction leading to an inspiration with a sufficient tidal volume via an external electromagnetic stimulation of the phrenic nerve.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •≥ 18 years of age
- •American Society of Anaesthesiologists Classification I or II
排除标准
- •Chronic lung disease
- •Preexisting diaphragmatic weakness
- •Neurologic disease with known motor weakness
- •Paralysis of the phrenic nerve
- •Contraindication for any movement in the cervical vertebrae
- •Conditions that limit the movement of the diaphragm e.g. ascites, increased intraabdominal pressure, adipositas.
- •Inability to communicate in the official language
- •Infections, lesions or stricture in the neck area
- •Implanted cardiac devices e.g. pace maker, defibrillator, event recorder
- •Implanted medical pumps e.g. left ventricular assist device
- •Metal implants in the upper body
- •Preganancy
结局指标
主要结局
Tidal volume generated by electromagentical stimulation of the phrenic nerve (ml)
时间窗: Study duration (approximately 10 minutes)
Mean tidal volume of 10 consecutively stimulations of the phrenic nerve
次要结局
- Tidal volume per breath(Study duration (approximately 10 minutes))
- Abdominal extension maximum(Study duration (approximately 10 minutes))
- Air pressure during each breath(Study duration (approximately 10 minutes))
- Max inspiratory flow after stimulation(Study duration (approximately 10 minutes))
- Diaphragmatic thickening fraction(Study duration (approximately 10 minutes))
- Latency between stimulation and feedback(Study duration (approximately 10 minutes))
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](Study duration (approximately 10 minutes))
- Feedback/Stimulation locus relation(Study duration (approximately 10 minutes))
- Intensity/Contractility relation(Study duration (approximately 10 minutes))
- Time to find the optimal stimulation point of the N. phrenicus(Study duration (approximately 10 minutes))
- Distance between anatomical landmarks and optimal stimulation locus(Study duration (approximately 10 minutes))
- Reproducibility of stimulation answer(Study duration (approximately 10 minutes))
研究者
Stefan J Schaller
Deputy Clinical Director
Charite University, Berlin, Germany