Development of Diaphragm Atrophy, Dysfunction and Inhibited Cortical Control in Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots.
研究概览
简要总结
The gold standard of twitch transdiaphragmatic pressure recordings would ultimately clear the fog around the rate of development of Ventilator induced Diaphragm Dysfunction (VIDD) in mechanically ventilated patients over time.
Through measurements made even after mechanical ventilation (MV) it could be clarified to what extent patients recover from VIDD.
Paired with cortical stimulation and electromyographic recordings of diaphragm muscle potentials, it could be explored to what extent decreased diaphragm excitability due to long term MV contributes to VIDD on the level of motor cortex.
Against that background the present project aims at determining the rate of decline in diaphragm function, strength and control in patients undergoing MV (including measurements after extubation).
详细描述
Evidence both from animal and human studies support the development of ventilator induced diaphragm dysfunction (VIDD) from as early as 24 hours of mechanical ventilation (MV) in the intensive care unit (ICU).
However, while the concept of VIDD seems to be proven now, several questions remain unanswered regarding its actual rate of development and (potentially) recovery after MV.
The gold standard of twitch transdiaphragmatic pressure recordings would ultimately clear the fog around the rate of development of VIDD over time.
Through measurements made even after MV it could be clarified to what extent patients recover from VIDD.
Paired with cortical stimulation and electromyographic recordings of diaphragm muscle potentials, it could be explored to what extent decreased diaphragm excitability due to long term MV contributes to VIDD on the level of motor cortex.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Initiation of invasive mechanical ventilation in the Intensive Care Unit within 48 hours.
- •Expected duration of invasive mechanical ventilation of at least 5 days.
- •OR: elective bypass surgery with "planned" invasive mechanical ventilation
排除标准
- •Body-mass-index (BMI) >40
- •Expected absence of active participation of the patient in study-related measurements after extubation
- •Alcohol or drug abuse
- •Non MRI compatible implant in the body
- •Slipped disc
- •Patients in an interdependence or with an employment contract with the principal investigator, Co-PI or his deputy.
研究组 & 干预措施
Invasively ventilated patients (n=20)
First measurement (comprehensive protocol) within 48 hours from initiation of MV.
Serial measurements every third day including 2 measurements after extubation.
干预措施: Respiratory Muscle Testing (Diagnostic Test)
结局指标
主要结局
Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots.
时间窗: 2 years
Cortical control of diaphragm function
时间窗: 2 years
Amplitude of the diaphragm motor evoked potentials (measured by surface electrodes attached to the diaphragm) following cortical magnetic stimulation of the phrenic nerve roots.
次要结局
- Systemic inflammation(2 years)
- Diaphragm ultrasound(2 years)
研究者
Univ.-Prof. Dr. med. Michael Dreher
Professor Michael Dreher
RWTH Aachen University