Electromagnetic Stimulation of the Phrenic Nerve to Generate Contraction of the Diaphragm in Critically Ill Mechanically Ventilated Patients - a Proof-of-concept Study (STIMIT-II)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Frequency of non-feasible stimulation, due to organisational or patient-specific reasons.
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 in critically ill ICU patients via an external electromagnetic stimulation of the phrenic nerve, leading to an inspiration (i) with a sufficient tidal volume (3-6 ml/kg ideal body weight) and (ii) with verifiable muscular diaphragmatic contraction through ultrasound imaging.
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 in critically ill ICU patients via an external electromagnetic stimulation of the phrenic nerve, leading to an inspiration (i) with a sufficient tidal volume (3-6 ml/kg ideal body weight) and (ii) with verifiable muscular diaphragmatic contraction through ultrasound imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Patients between 18 and 60 years old, hospitalized in ICU
- •Mechanical ventilation < 36 h
- •Prone to stay ventilated > 72 h
排除标准
- •Known neurological condition affecting motor neuron or muscle (e.g. ALS)
- •Known paralysis of the phrenic nerve
- •Proven or suspected spinal cord injury that contraindicates weight bearing on the spinal cord
- •Conditions that limit diaphragm movement (high intra-abdominal pressure, ascites, obesity)
- •Not able to read and understand the national language German
- •Patients with Implanted cardiac support systems (pacemaker, implanted defibrillator)
- •Patients with implanted medical pumps
- •Pregnant patients
- •Patients with skin lesions, infections or strictures in throat/neck area
- •Patients with metallic implants
结局指标
主要结局
Frequency of non-feasible stimulation, due to organisational or patient-specific reasons.
时间窗: 10 days
Percentage of non-feasible stimulation out of the total number of stimulations planned according to the investigation protocol.
Time to find the optimal stimulation point of the N. phrenicus
时间窗: Study duration (10 days)
Time between first successful N. phrenicus stimulation and identification of the optimal stimulation locus in seconds
Frequency of sufficient Tidal volume generated by electromagentical stimulation of the phrenic nerve (3-6 ml/kg ideal body weight)
时间窗: Study duration (10 days)
Percentage of stimulated breaths above the cut-off Today volume (3-6 ml/kg ideal body weigh) out of the total number of stimulated breaths. Tidal volumes are measured by the mechanical ventilator.
次要结局
- Stimulated tracheal pressure during electromagentical stimulation of the phrenic nerve(Study duration (10 days))
- Lung resistance during electromagentical stimulation of the phrenic nerve(10 days)
- Maximal inspiratory pressure (MIP) during electromagnetical stimulation of the phrenic nerve.(Study duration (10 days))
- Correlation between amplitude and duration of sEMG signals during stimulated breathing.(Study duration (10 days))
- Rapid Shallow Breathing Index (RSBI) record and evaluation.(Study duration (10 days))
- Lung compliance during electromagentical stimulation of the phrenic nerve(10 days)
- Variance of Tidal volume generated by electromagentical stimulation of the phrenic nerve(Study duration (10 days))
- Transpulmonary pressure during electromagnetical stimulation of the phrenic nerve(Study duration (10 days))
- Occlusion pressure during electromagnetical stimulation of the phrenic nerve(Study duration (10 days))
- Diaphragm thickening fraction(approx. 28 days (till ICU discharge))
- Diaphragm excursion(approx. 28 days (till ICU discharge))
- Expiratory and Inspiratory Diaphragm Thickness measured by Ultrasound(Study duration (10 days))
研究者
Stefan J Schaller
Deputy Clinical Director
Charite University, Berlin, Germany