Effects of Early Musical Intervention on Prevalence and Severity of Paroxysmal Sympathetic Hyperactivity After Severe Traumatic Brain Injury: the Prospective Randomized MUSIC-TCNV Trial.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Paroxysmal Sympathetic Hyperactivity Assessment Measure [PSH-AM] (ranging from 0 to 29)
研究概览
简要总结
Paroxysmal sympathetic hyperactivity (PSH) is a frequent symptom after traumatic brain injury and concerns up to 30% of severely brain-injured patients.
PSH is due to unbalanced autonomic nervous system activity, resulting in sympathetic surges causing hypertension, tachycardia, sweating and hypertonia. The affected patients suffer more pain, more cardiovascular distress, more infections and prolonged rehabilitation and mechanical ventilation; additionally it could lead to a worse outcome.
Classical music was shown to reduce autonomic nervous system imbalance in healthy people and in many medical diseases. It could be a means to dampen sympathetic surges for brain-injured patients presenting with PSH, as well.
Our study aims at demonstrating that early musical intervention, started with the weaning of sedation, can reduce both the prevalence and the severity of paroxysmal sympathetic hyperactivity in traumatic brain-injured patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe traumatic brain injury (either initial Glasgow Coma Scale < 8 or intracranial pressure > 20mmHg for more than 20 min)
- •National health service coverage
- •Informed consent signed by next of kin
排除标准
- •Non-traumatic brain injury
- •Conditions interfering with measures: bilateral fixed pupils, temporal bone fracture including acoustic channel, eye trauma, previous eye surgery, otorrhagia, hypoacusis,
- •Preexisting autonomic nervous system imbalance: severe diabetes, arrhythmias, pace maker, implantable defibrillator, cardiac transplantation
- •Respiratory rate < 9/min
- •Patient subject to guardianship or wardship
- •Pregnant or breastfeeding woman
- •Current participation in another biomedical research protocol
结局指标
主要结局
Paroxysmal Sympathetic Hyperactivity Assessment Measure [PSH-AM] (ranging from 0 to 29)
时间窗: from desedation (Day 0) to Day 21.
The PSH-AM combines the sum of Clinical Features Scale \[CFS\] (from 0 to 18) and the Diagnostic Likelihood tool \[DLT\] (from 0 to 11)
次要结局
- Area under the Clinical Features Scale curve(from Day 0 to Day 21.)
- Mean Analgesia Nociception Index(from Day 0 to Day 21.)
- Neurological Pupil Index(from Day 0 to Day 21.)
- Neurological outcome (Wessex Head Injury Matrix)(from Day 0 to Day 21.)
- PSH-AM(Six and twelve months)
- Disability Rating Scale(Six and twelve months)
- Pain (Critical-Care Pain Observation Tool)(from Day 0 to Day 21.)