Inspiratory Muscle Strength and Respiratory Complications After Spinal Cord Injury: a Multicenter, Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Pneumonia
研究概览
简要总结
The investigators conducting this study to investigate the relation between the respiratory muscle strength and respiratory complications. To understand more about respiratory complications the influence of different factors (such as in- and expiratory muscle strength, lung function parameters, physical activity, smoking, medications,...) on respiratory complications (such as pneumonia) will be investigated.
详细描述
Background:
A spinal cord injury (SCI) often leads to paralysis of respiratory muscles (1), which causes a decrease in inspiratory volume and consequently limits the pre-cough volumes needed to produce an effective cough (2). The ability to cough is essential for airway clearance (3). With reduced cough capacity, the risk for pneumonia is increased (1). Pneumonia is still among the leading causes of death in the SCI population (4, 5). In acute SCI, up to 80% of patients are affected by respiratory complications (6) and in 51 % of these cases pneumonia occurs (7), corresponding to a cumulative pneumonia incidence rate of about 40%. Unfortunately, predictors of pneumonia in SCI are still poorly understood (6).
To the investigators knowledge, there are three studies on predictors of pneumonia in the SCI population (8, 9).
Two of these studies concentrated on factors of injury and shock severity (9) or identified the level and completeness of injury as the fundamental clinical entity predicting pulmonary complications (8).
However, both studies did not investigate potentially modifiable factors. The third study focused on potentially modifiable factors, such as lung function but did not cover respiratory muscle strength and did not define the inclusion of respiratory complications precisely (10). Therefore, to facilitate future evidence-based strategies to reduce the pneumonia risk in acute SCI, prevention targeted studies that aim to identify modifiable risk factors for pneumonia are urgently needed.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Initial rehabilitation after SCI
- •men and women
- •aqe over or equal 18 years
- •AIS A, B, C or D lesion
- •lesion level C1-T12
排除标准
- •Neurologic diseases (e.g. MS, ALS)
- •24h mechanical ventilation dependency
- •mental disorders
结局指标
主要结局
Pneumonia
时间窗: From date of spinal cord injury until discharge from primary rehabilitation (i.e. individual time window of observation from a few weeks to about 1 year)
occurrence of pneumonia
次要结局
- Respiratory Function Measurements(measured at inclusion at 28±12 days post injury (time window) or at 84±14 days post injury (time window) - first measurement of each patient used for analysis)
- Mortality Due to Pneumonia(From date of spinal cord injury until discharge from inpatient rehabilitation (i.e. individual time window of observation from a few weeks to about 1 year))
- Respiratory Muscle Strength(measured at inclusion at 28±12 days post injury (time window) or at 84±14 days post injury (time window) - first measurement of each patient used for analysis)